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How drugs are licensed

Nearly all drugs used in the UK are licensed through the European Medicines Evaluation Agency (EMEA). A licence from the EMEA is valid in all the countries of the EU. Before the EMEA was formed, pharmaceutical companies had to apply to each country individually for a licence.

Each application for a license for a new drug is passed on for assessment to the Committee for Proprietary Medicinal Products (CPMP). This committee is part of EMEA. The committee selects representatives from two member states to consider the application, one of whom is chosen by the pharmaceutical company. Their assessments form the basis for the final approval by the CPMP. Following assessment the CPMP gives an opinion on the application. This is then considered by the EU Commission, which acts as the licensing authority.

The CPMP works to a strict timetable laid down in EU law. An opinion (positive or negative) has to be issued within 210 days of receipt of the application, although the company may stop the procedure at any time.

If the opinion is negative the company must answer questions raised by the CPMP before the application can progress. If a positive opinion is issued, the EU Commission requests comments from other member states, which have 28 days to respond. If a licence is recommended a European Public Assessment Report (EPAR) is produced and marketing authorisation issued.
Once a drug has EU marketing authorisation, it is licensed, registered or approved. All these terms mean the same thing.

The pharmaceutical company can now market the drug in any EU country, but first has to apply to market their product in each individual country within the EU. In the UK, they will apply to the Medicines and Healthcare Products Regulatory Agency (MHRA).

Once a drug has been licensed doctors can prescribe it on the NHS or through private health care. The use of the drug is limited to 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 may be reluctant to prescribe a new drug at this early stage as 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 that the drug is both safe and effective.

NICE - The National Institute for Clinical Excellence

Some hospitals or primary care trusts will not allow their doctors to prescribe new drugs until they have been approved by The National Institute for Clinical Excellence (NICE) in England and Wales, or by the Scottish Medicines Consortium in Scotland. These organisations not only look for evidence that the drug works, but also at any drawbacks or limitations it has as well as at its cost effectiveness.

It is also the role of NICE to look at particular drugs when there is confusion or uncertainty over their value. They also monitor prescribing practices. These can vary, meaning that patients may be receiving different treatments based on the particular area they happen to live in, rather than on the state of their health.

NICE was set up to try to end this uncertainty and inequality about prescribing. Once NICE publishes guidelines, health professionals and the organisations that employ them are expected to take them fully into account when deciding what treatments to give people. However, NICE’s guidance does not replace the knowledge and skills of individual health professionals who treat patients. Ultimately it is still up to them to make decisions about a particular patient.

Unfortunately, the workloads of NICE and the Scottish Medicines Consortium are considerable, and there is often a backlog of new treatments waiting for approval. This is particularly true for NICE. A situation sometimes occurs where the SMC has approved a new drug for use in Scotland, but because of the backlog NICE have not yet approved it for use in England and Wales.

There may also be difficulties once 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. However, once NICE has made a recommendation, as it has for pegylated interferon and ribavirin, patients have a right to the drug provided they meet the criteria laid down in the recommendation.