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Approving innovative medicines

Before a new medicine can be used in the UK, it must be licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA), which ensures medicines meet rigorous standards of quality, safety and efficacy.

Before it can be approved for routine NHS use in England, a medicine is also evaluated by the National Institute for Health and Care Excellence (NICE), which assesses whether it represents value for money for patients and the NHS.

NICE recommendations are also followed in Wales and Northern Ireland. In Scotland, the Scottish Medicines Consortium (SMC) conducts the value assessment.

Improving patient access

The way a new medicine is valued for NHS use has changed.

The first increase to NICE’s cost-effectiveness threshold in over twenty years is a step in the right direction to improving patient access to medicines. Nine new treatments which would otherwise not have been available to NHS patients were approved in just the first three months since the changes came into force. These include medicines for blood disorders, autoimmune diseases and several adult and childhood cancers.

This is an important step towards ensuring NHS patients can benefit from innovative medicines more quickly. It begins to address a longer-term challenge: compared with many similar European countries, the UK has invested proportionally less in medicines. The UK spends just 9 per cent of its healthcare budget on medicines, compared to 17 per cent in Italy, 14 per cent in Germany and 13 per cent in France¹.

Increasing investment in innovative medicines will help ensure patients can access the latest treatments while improving long-term health outcomes.

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¹ IQVIA Institute for Human Data Science, ‘Drug Expenditure Dynamics 2000–2022’, 2025. Sponsored by the ABPI. Drug Expenditure Dynamics 2000–2022 | IQVIA

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