Early Access to Medicines Scheme (EAMS) Consultation
We're looking for your views and comments on our proposed legislative changes to clarify the legal basis for EAMS.
The UK Early Access to Medicines Scheme (EAMS) is one of the ways through which a patient with a life threatening or seriously debilitating condition can gain access to a medicine before it has gained approval from the UK’s medicines regulatory authority.
The aim of this proposal is to ensure that EAMS remains an attractive option for patients, healthcare professionals and companies, so that cutting-edge therapies are available for patients where there is an unmet clinical need.
We aim to make the legal basis for EAMS supply clear and minimise the burden on those supplying EAMS medicines and for those companies wishing to collect real-world data during the scheme. This will be delivered whilst continuing to ensure the safety of EAMS products through pharmacovigilance (safety monitoring), maximising patient access and benefit.
We’d value your views on the proposed legislative changes to clarify the legal basis for EAMS and welcome you to respond to a few of our questions using the link here.
The consultation is open from 09:00 am on 06 August 2021 until 11:45 pm on 17 September 2021. We aim to consider all your comments as quickly as possible and use them to inform the drafting of our legislative proposals thereafter.
The consultation can be found using the first link below.
The consultation questions can be found here