Access to medicines in England

Patients in the UK should be able to benefit from the latest innovative medicines and vaccines as quickly as possible.

Before medicines or vaccines can be used to treat patients in the UK, they must be licensed by the Medicines and Healthcare Regulatory Agency (MHRA). However, regulatory approval is only one step on the journey to patient access on the NHS.

Medicines and vaccines also need to be assessed to ensure they are a clinically and cost-effective use of NHS resources. In England, this assessment is carried out by the National Institute for Health and Care Excellence (NICE) for medicines and the Joint Committee on Vaccination and Immunisation (JCVI) for vaccines. Northern Ireland and Wales broadly follow NICE guidance*, while in Scotland, the assessment is done by the Scottish Medicines Consortium (SMC).

The graphic below shows all the different uses (“indications”) of medicines and vaccines approved by the European Medicines Agency (EMA), the UK's MHRA equivalent, between 2022 and 2025. The graphic tracks each of these indications through the regulatory and reimbursement processes to see if they are available to NHS patients in England.

The aim is to provide a picture of access to medicines and vaccines in England vs those licenced for use in Europe.

The graphic shows how many medicines and vaccines have:

reached NICE for assessment
been recommended for use, both for all potential patients and for a subset (known as an 'optimised' recommendation)
are not yet, or may never be, available on the NHS

Access to medicines in England

EMA approvals represent only a proportion of global medicine and vaccines approvals. If the graphic were to consider all indications for all medicines and vaccines approved worldwide, including those in larger countries and regulated by agencies such as the US Food and Drug Administration (FDA), the proportion available to patients on the NHS in England would be even smaller.

Understanding the graphic

EMA total = All indications approved by the EMA from January 2022 to the end of December 2025, excluding minor extensions such as small changes to age ranges or patient weight limits.
Non-NICE access = Indications available in England through routes other than a NICE appraisal, such as NHS specialised commissioning, vaccines, or medicines with UK sales data showing they are being used.
Reached NICE = Indications that have been considered by NICE.
No UK data = Includes medicines which have been approved by the MHRA, but have not been assessed by NICE, do not appear in NICE’s forward work programme and show no evidence of any UK sales. On that basis, these medicines are assumed not to be available to NHS patients, with no future plans to make these medicines available.
No MHRA approval = Indications which have a licence from the EMA for use in Europe, however, do not have a licence from the MHRA for use in the UK
NICE pipeline = Indications that are awaiting assessment or are in development by NICE as of the end of 2025.
Completed NICE appraisal = Indications where NICE reached a final decision to recommend or not recommend use on the NHS. This does not include terminated appraisals.
Recommended for use on the NHS = Indications that NICE recommended for use on the NHS, either in full or for a narrower group of patients.
Full recommendation = Indications recommended by NICE for use in line with the full marketing authorisation.
Optimised = Indications recommended by NICE for only part of the licensed patient population.
Not recommended = Indications that NICE decided not to recommend for use on the NHS.
Terminated = Indications where the NICE appraisal was stopped before a final recommendation was made or no submission was made by the company.
Footnotes:
- Indications are the different diseases or groups of patients within a disease which a medicine or vaccine can be used for. Different indications for a medicine or vaccine tend to be approved at different times, hence the graphic above considers the data on an indication, rather than medicine / vaccine level, to provide as detailed a picture as possible.
- *The graphic assesses approvals by NICE and therefore focuses on access to medicines in England. For a medicine to be available in Scotland, it must be approved by the Scottish Medicines Consortium (SMC). For a medicine to be available in Wales and Northern Ireland, often a NICE recommendation suffices, however the All-Wales Medicines Strategy Group (AWMSG) also carry out their own appraisals on certain medicines that NICE has not evaluated.