Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if his Department will make an assessment of the potential merits of increasing the funding for early access programmes.

There are no current plans to increase funding for medicines supplied through early access programmes. The early access to medicines scheme (EAMS) was formed in 2014 and aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. In 2022, EAMS was introduced into the Human Medicines Regulations 2012. EAMS products are classed as unlicensed medicines within the regulations. Additionally, within the regulations, there is no comment on the ability to charge for supply, however, it is stated in the Medicines and Healthcare products Regulatory Agency’s (MHRA) guidance that there should be no charge for supply of these medicines under the EAMS programme.

Outside of EAMS, companies may put in place early access programmes (EAPs) to allow early access to new medicines that do not yet have a marketing authorisation. These are not approved by the MHRA and participation in such programmes is decided at an individual National Health Service trust level. Under these programmes, the cost of the drug is free to both patients taking part in it, and to the NHS, but NHS trusts must still cover administration costs.

NHS England has published guidance for integrated care systems (ICS) on free of charge medicines schemes such as EAPs, including providing advice on potential financial, administrative, and clinical risks. The guidance aims to support the NHS to drive value from medicines and ensure consistent and equitable access to medicines across England. ICSs should follow the recommendations to determine whether to implement any free of charge scheme, including assessing suitability and any risks in the short, medium, and long term. The guidance is available at the following link:

https://www.england.nhs.uk/long-read/free-of-charge-foc-medicines-schemes-national-policy-recommendations-for-local-systems/