How are drugs licensed in the UK?
This page tells you about the drug licensing process in the UK. There is information below on
Before any medicines can be used in the UK they have to be licensed. Drugs are licensed for use in the UK either with a European licence or a national licence. Drugs are either licensed through the
- European Medicines Agency (EMA) for a Europe wide licence
- Medicines and Healthcare products Regulatory Agency (MHRA) for a UK licence
Below there are explanations of what these two agencies do.
In 2003, the Medicines Control Agency (MCA) merged with the Medical Devices Agency (MDA) to form the Medicines and Healthcare products Regulatory Agency (MHRA). They now license drugs in the UK. They support the European process as part of the EMEA. They also act as the sole agents for companies who only want to license a drug in the UK.
A pharmaceutical company can apply directly to the MHRA for a UK licence. Or they can apply to the EMEA for a EU licence. Nearly all drugs in the EU are licensed through the EMEA now. This is because a single EMEA licence is valid in all the countries of the EU. Before the EMEA was formed, companies had to apply to each country individually for a licence.
The EMEA co-ordinate drug licence applications within the European Union (EU). There are 6 committees within the EMEA. Each committee looks at a particular area. For example there is a Committee for Proprietary Medicinal Products (CHMP) who are responsible for medicines for human use and one for the medicines for veterinary use called The Committee for Veterinary Medicinal Products (CVMP).
The other committee which you may hear about is The Committee for Orphan Medicinal Products (COMP) who are responsible for ‘orphan medicines’ for rare diseases. ‘Orphan medicines’ are drugs that are for preventing, diagnosing or treating a life threatening medical condition that affects fewer that 5 out of every 10,000 people in the European Union. The pharmaceutical company would not normally be able to make much profit from these drugs because so few people would need them. So they get incentives, such as
- Having to pay less in fees to license the drug
- A longer time than usual when only they can market the drug (market exclusivity)
- Extra money for research and development
There are different systems within the EMEA that pharmaceutical companies can use to license drugs.
The first is called the ‘centralised system’. Any drugs for AIDS, cancer, neuro-degenerative conditions, diabetes or orphan drugs have to be licensed this way. The committee that reviews drugs for human use (the CHMP) assess the application, and then recommend whether a drug should have ‘marketing authorisation’ (a licence) or not.
The other ways that pharmaceutical companies apply for a license is either the ‘decentralised system’ or the mutual recognition system. They will use these systems for medicines that don't fit into the categories within centralised system.
With the decentralised system the company applies to several member states at the same time. One member state assesses the application (this is the MHRA in the UK). If they recommend that the drug be licensed, the other member states then either agree or object. If everyone agrees, the drug is given marketing approval. If someone objects, the CPMP will step in and decide. They then advise the EU Commission whether to license the drug or not.
The 'mutual recognition' system means that if one member state already has an existing authorisation the company can apply for the same licence in other member states. The other member states can then mutually recognise the licence using the first member states assessment or they can object.
Once a drug has EU marketing authorisation, it is ‘licensed’, ‘registered’ or ‘approved’. All these terms mean the same thing. This means the company can market the drug in any EU country - but they don’t have to. For one reason or another, they may choose to market the drug in some countries but not others.
When a drug has marketing authorisation, it is not available straight away. The company first have to apply to market their product in each individual country. In the UK, they will apply to the MHRA. When this last small step is done, the product is ‘launched’, and doctors can prescribe it.
It is possible, but quite unusual, for pharmaceutical companies to apply for a licence in the UK alone. If they want to, the pharmaceutical company apply to MHRA for a licence. The Committee on Safety of Medicines (CSM) assess the application, and recommend whether the drug should get a licence or not.
If the CSM recommend that the drug shouldn't be licensed, the pharmaceutical company can appeal to the Medicines Commission. They are an advisory group. They look at the application again, and advise the MHRA whether to issue a licence or not.
As with EU approval, when a product is given marketing authorisation (a licence) by the MHRA, it cannot be prescribed until it is ‘launched’. The time it takes from marketing authorisation to launch in the UK is one of the fastest in the world.
After a product has been launched doctors are allowed to prescribe it, either on the National Health Service (NHS) or through private health care. But only for people who meet the specific criteria of the drug’s licence. This often includes specific stages or types of a disease - for example, a drug may be licensed for one type of cancer, but not for another.
In practice, some doctors are not happy to prescribe a new drug at this early stage. There may be a lack of information available about side effects or long term safety. Some doctors like to wait for more information to be published so they can be sure the drug is both safe and effective.
For prescribing on the NHS, some hospital or primary care trusts won't let their doctors prescribe new drugs until they have been approved by NICE (The National Institute for Health and Clinical Excellence) in England and Wales or the SMC (Scottish Medicines Consortium) in Scotland. These organisations look at the evidence on how well the drug works, on any drawbacks or limitations and on cost effectiveness. Unfortunately, there is such a large amount of this work to do and it is so time consuming that there is often a backlog of new treatments waiting for approval. This is particularly so for NICE. The situation sometimes occurs where the SMC has approved a new drug for use in Scotland but NICE have not yet approved it for use in England and Wales. NICE have introduced a fast track process to evaluate drugs more quickly.
There may also be difficulties after a drug has been licensed and approved by NICE. Some health authorities are still reluctant to prescribe drugs approved by NICE or the SMC because of the cost. This is an issue that is being addressed at Government level.
You can find more information about how drugs are licensed from the MHRA and the EMA (European Medicines Agency) .
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