Read about what the Early Access to Medicines Scheme (EAMS) is and how the EAMS makes decisions.
What is it
The Early Access to Medicines Scheme started in March 2015. It is a process that aims to give people access to promising new drugs that are not yet licensed. The licensing process for drugs makes sure:
- they are safe
- they work
- the benefits outweigh any possible side effects
Medicines within the Early Access to Medicines scheme haven't gone through the full licensing process. This means that there may still be some uncertainties about how safe these drugs are, 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 to be licensed.
How long it takes
It can take many years for new medicines to go through the research and licensing process. After being licensed, the drugs also need to be approved by other organisations before doctors can prescribe them. These organisations decide which drugs work well and are cost effective to use. The organisations that approve medicines are:
- The National Institute for Health and Care Excellence (NICE) in England
- The Scottish Medicines Consortium in Scotland
- The All Wales Medicine Strategy Group (AWMSG) in Wales
In England, if a licensed medicine is still being considered by NICE, you might be able to get it through the Cancer Drugs Fund.
Off label drugs
The Early Access to Medicines Scheme can be used to give doctors information to support a decision to prescribe a drug off label. Off label means that a doctor prescribes a drug for a condition, an age group, or at a dose, that it is not licensed for.
The scheme is only for drugs that might be of benefit to people with a life threatening, or seriously debilitating condition, and when no other treatment is available to them.
The EAMS is run by the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA is the UK government organisation that makes sure all medicines and equipment used in healthcare work properly and is 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 to the MHRA for a Promising Innovative Medicine (PIM) designation. This means that the company gives the MHRA the results of available research about the medicine.
PIM is designed 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. If the MHRA decides that doctors can prescribe the drug, the 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:
- what the medicine is
- which conditions it can be used to treat, such as a particular type and stage of cancer
- how the medicine works
- who can give the medicine
- a summary of the available research
- why the MHRA has made the decision
- any uncertainties about the use of the medicine for this condition
- possible benefits and side effects
- whether the drug is in any on-going research
- how the MHRA will monitor and manage any risks