About EAMS
The early access to medicines scheme (EAMS) aims to give people with life threatening or seriously debilitating conditions access to unlicensed medicines when there is no other treatment option. The ADTC Collaborative develops guidance on the use of these medicines in Scotland.
The licensing process for medicines is also known as marketing authorisation. It ensures the medicine is
• safe
• effective
• the benefits outweigh possible side effects.
The licensing process can take several years. Research may show a medicine is promising treatment for people who have no other options. It may then be eligible for EAMS.
The Medicines and Healthcare products Regulatory Agency (MHRA) oversee EAMS. You can find out more about the scheme on their website.
Pharmaceutical companies can meet with ADTC Collaborative and Scottish Medicines Consortium (SMC) representatives to develop guidance for use of EAMS medicines in Scotland. This also provides an opportunity to discuss the SMC assessment process.
Once the medicine receives a licence it can be assessed for routine use by the SMC.
Medicines with Promising Innovative Medicine (PIM)
The PIM designation indicates that a product may be eligible for the EAMS based on early clinical data. However, it could be several years before the product is licensed and not all medicines with PIM designation become part of an EAMS. Companies with a medicine with PIM designation are invited to attend a meeting with ADTCC and SMC to discuss operational delivery of EAMS and the implications for future health technology assessment.
Our guidance on EAMS
The ADTC Collaborative works with pharmaceutical companies that have applied for EAMS to develop operational guidance. This guidance helps NHS boards manage access to EAMS medicines. The guidance highlights key operational issues for the EAMS medicine for health boards including;
- supply arrangements
- patient information
- pharmacovigilance requirements
- EAMS termination arrangements
EAMS period
EAMS were intended to be in place for 12 – 18 months. In practice, they have been very brief, with some only lasting a few months. Some EAMS medicines also have a “winding down period” after marketing authorisation. More information is available on the Early access to medicines scheme (EAMS): how the scheme works – GOV.UK (www.gov.uk).
The length of the EAMS period depends on:
- when the company submits an application for the EAMS scheme
- when the marketing authorisation is issued
- if the EAMS has a “winding down period”
SMC and ADTCC have no influence on this process.
Marketing authorisation
Companies apply for marketing authorisation at the same time as PIM/EAMs activity.
Submissions to SMC
A company may make a submission for a product once it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) or before final approval from the Medicine and Healthcare products Regulatory Agency.
You can find out more about how to make a submission on the SMC’s website.