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The UK's post-Brexit scheme, launched in 2021 and refreshed in 2025, that brings the medicines regulator, NICE and the NHS together early in a drug's development so that licensing and the decision to pay for it can happen close together.
United Kingdom, regulatory scheme. The Innovative Licensing and Access Pathway (ILAP) was launched in January 2021 by the Medicines and Healthcare products Regulatory Agency (MHRA) with the National Institute for Health and Care Excellence, the Scottish Medicines Consortium and the All Wales Therapeutics and Toxicology Centre, and NHS England later joined as a partner. The MHRA relaunched a refreshed pathway in 2025 with tighter entry criteria and a focus on products likely to reach NHS patients. Primary text: the GOV.UK guidance.
How it works: a developer applies for an Innovation Passport for a medicine addressing a life-threatening or seriously debilitating condition or a significant patient or public health need; the partners then agree a Target Development Profile setting out the regulatory and access milestones, and the developer can draw on a toolkit including enhanced scientific advice, adaptive inspections and the Early Access to Medicines Scheme (EAMS, since 2014), which allows supply before licensing on a positive scientific opinion. Since January 2024 the MHRA's International Recognition Procedure separately allows fast licensing of medicines already approved by trusted regulators such as the FDA and the EMA.
The arguments: ILAP was designed to keep the UK attractive for launches after leaving the EMA network, and cancer medicines are a large share of passports; critics note that a passport does not change the evidence needed, that early uptake was slow and that the value of the pathway depends on NICE and NHS England committing to timelines, which the refresh sought to fix. The Cancer Drugs Fund remains the main route for early NHS access to uncertain cancer medicines.
Shares NICE technology appraisal methods (2022), NICE cancer guidance and technology appraisals (UK), Cancer Drugs Fund (England), Health technology assessment (HTA), reimbursement and QALYs and the tags law, uk.
Shares Medicines and Medical Devices Act 2021, Medicines and Healthcare products Regulatory Agency and the tags law, uk.
Shares Medicines and Medical Devices Act 2021, Project Orbis, Fast Track and RMAT designations, France: early access (accès précoce), formerly ATU and the tag law.
Shares Fast Track and RMAT designations, Breakthrough Therapy / Priority Review / Priority Voucher, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Regulatory divergence between regions and the tag law.
Shares France: early access (accès précoce), formerly ATU, NICE technology appraisal methods (2022), Health technology assessment (HTA), reimbursement and QALYs, Regulatory divergence between regions and the tag law.
Shares France: early access (accès précoce), formerly ATU, NICE technology appraisal methods (2022), Health technology assessment (HTA), reimbursement and QALYs and the tag law.
Shares Fast Track and RMAT designations, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Regulatory divergence between regions and the tag law.
Shares Fast Track and RMAT designations, Breakthrough Therapy / Priority Review / Priority Voucher, Regulatory divergence between regions and the tag law.