Early Access to Medicines Scheme

The Early Access to Medicines Scheme (EAMS) gives people access to promising new medicines that are not yet licensed. This scheme applies to Scotland, Northern Ireland, Wales and England.

About the EAMS

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 medicines makes sure:

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

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

Medicines within the EAMS haven't gone through the full licensing process. They might still be part of ongoing research, or they may be waiting for a licence.

This means that there may still be some uncertainties about how safe these medicines are. Researchers also wouldn't know yet how well they work, and what side effects they may cause.

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 medicine needs to look promising. The medicine 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 medicine can apply for a Promising Innovative Medicine (PIM) designation. They do it through the MHRA. The company gives the MHRA the results of available research on the medicine.

The PIM gives 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 scientific opinion. During this process, the MHRA decides whether doctors can prescribe a medicine.

The scientific opinion considers the risks and benefits of the medicine. This information comes from the patients who have had the medicine. It gives information for the doctor and patient.

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

Public Assessment Report (PAR)

If the scientific opinion is positive, the MHRA produces a public assessment report (PAR). This has information about:

• how the medicine is used and how it works
• summary of the key clinical studies
• the risks and benefits of the medicine
• 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.

Off label medicines

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

• condition
• age group
• dose

Safety

The medicines in the EAMS scheme are new. So researchers are still finding out about how well they work and what side effects they cause. This means you may have side effects that doctors don't know about yet.

Reporting to the MHRA

The pharmaceutical company provides regular updates to the MHRA. This is to check how well the new medicine works. The updates also include any side effects. The company has to do this as part of their agreement to be able to supply the medicine. They give reports at least every 3 months, but for some drugs, it might be more often.

Reporting to the pharmaceutical company

Your doctor will give the pharmaceutical company regular updates. These include the results of any tests and side effects you have. If you have any serious side effects, your doctor, nurse or pharmacist need to report them within 24 hours. They should report any other effects within 5 days. Your doctor will also report any side effects to the MHRA.

Patient Alert Card

Your doctor will give you a Patient Alert Card. You should carry this card with you at all times. The card has information about the medicine you are taking and its known side effects. It has the contact details for your cancer doctor and specialist nurse.

What to do if you want an EAMS medicine

There are only a small number of medicines that can be accessed through EAMS.

Talk to your doctor if you think that an EAMS medicine is suitable for you. If you want to have an EAMS medicine and your doctor agrees, your doctor applies to the manufacturer and your local NHS.

You might feel disappointed if you can’t have the treatment you would like. This can be very difficult to come to terms with. You might feel a range of emotions, including anger.

It can be helpful to talk to your specialist. Ask them whether there are other treatments you can have or if you can take part in a clinical trial.

You might be able to talk with other people who have tried to get the same treatment. It can be helpful to share experiences.