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
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) designation
The Promising Innovative Medicine (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