About the Early Access to Medicines Scheme

The Early Access to Medicines Scheme (EAMS) gives people access to promising new drugs that are not yet licensed.

What it is

The EAMS started in April 2014. It aims to give people with life threatening or severely debilitating conditions access to medicines. Doctors can use the scheme when no other treatment is available for these conditions.

Usually, the licensing process for drugs makes sure:

  • they are safe
  • they work
  • the benefits outweigh any possible side effects

Medicines within the EAMS haven't gone through the full licensing process. This means that there may still be some uncertainties about how safe these drugs are. Researchers also wouldn't know yet how well they work, and what side effects they may cause.

The medicines might still be part of ongoing research, or they may be waiting for a license.

How long it takes

It can take many years for new medicines to go through the research and licensing process. After getting a license, other organisations also need to approve the drugs. Only then can doctors prescribe them.

These organisations decide which drugs work well and are cost effective to use. They are:

  • The National Institute for Health and Care Excellence (NICE) in England
  • The Scottish Medicines Consortium (SMC) in Scotland
  • The All Wales Medicine Strategy Group (AWMSG) in Wales

In England, if NICE is still considering a licensed medicine, you might be able to get it through the Cancer Drugs Fund.

Off label drugs

Doctors can get information from the EAMS to support a decision to prescribe a drug off label. Off label means that a doctor prescribes a drug that does not have a license for the:

  • condition
  • age group
  • dose

Making decisions

The Medicines and Healthcare Products Regulatory Agency (MHRA) runs the EAMS. The MHRA is a UK government organisation. It makes sure all medicines and equipment used in healthcare work and are safe.

To enter the scheme, the research into a new drug needs to look promising. The drug will have gone through phase 1 and 2 trials to look at its safety. It may also have gone through phase 3 trials.

Promising Innovative Medicine (PIM)

The company who makes the drug can apply for a Promising Innovative Medicine (PIM) designation. They do it through the MHRA. This means that the company gives the MHRA the results of available research on the medicine.

The PIM aims to give an early signal that the medicine may be a possible choice for the EAMS scheme. It might be able to help people who have no other treatment options.

Early Access Scientific Opinion

The next stage is the Early Access Scientific Opinion. During this process, the MHRA decides whether doctors can prescribe a drug.

The scientific opinion describes the risks and benefits of the medicine. This information comes from the patients who will be using the medicine. It supports the doctor and the patient.

A positive scientific opinion lasts for a year. The company can then apply to renew it.

Public Assessment Report (PAR)

The MHRA produces a public assessment report (PAR). This has information about:

  • how the product is used and how it works
  • summary of the key clinical studies
  • the risks and benefits of the product
  • the reason for the positive EAMS scientific opinion
  • any uncertainties
  • information about ongoing clinical studies
  • measures in place to check and manage risk

Look through the public assessment report (PAR) with your doctor. You can decide together if the treatment is the right choice for you.

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