In order for drugs to be prescribed and sold in the UK, they must first be licensed.
How are drugs licensed?
Drugs can be licensed in two different ways; either by the Medicines and Healthcare products Regulatory Agency (MHRA) or via the European Medicine Evaluation Agency (EMEA). The EMEA was introduced by the European Union in 1995.
European Medicine Evaluation Agency
The European Medicine Evaluation Agency is made up of three committees:
- Committee for Proprietary Medicinal Products (CPMP); this committee deals with drugs for human use.
- Committee for Veterinary Medicinal Products (CVMP); this committee deals with drugs for animals.
- Committee for Orphan Medicinal Products (COMP); this committee deals with ‘orphan medicines’ which are used to treat very rare diseases, which affect fewer than 5 people out of every 10,000 in the European Union.
Each committee is made up of two representatives from each member country.
The Medicines and Healthcare products Regulatory Agency
The MHRA is responsible for licensing drugs in the UK; pharmaceutical companies can apply to the MHRA for a license in the UK or to EMEA for an EU license. Most pharmaceutical companies apply for EU licenses.
Drug companies can apply for an EU license via the decentralised or centralised system. The centralised system involves the CPMP committee reviewing the application, while the decentralised system involves one member state approving the drug and then the other member states either agreeing or disagreeing. The centralised system must be used for drugs that are used to treat AIDS, cancer, diabetes and neuro-degenerative conditions.
Once a drug has marketing authorisation, the drug is then licensed. Once the drug has been licensed, it can then be prescribed according to the specific stipulations of the license. For example, a drug may be prescribed for one form of cancer but not licensed for other forms of cancer.
NICE
In the UK, drugs must be approved by NICE (National Institute of Clinical Excellence). NICE makes decisions based on research and published evidence and takes factors such as cost and availability into account. The government are currently trying to speed up the approval process, as it can sometimes take up to two years for NICE to approve a drug.
Other countries have approval bodies, such as FDA (Food and Drug Administration) in America. These bodies are responsible for approving the prescription and distribution of drugs.
