Could ILAP Open a New Route for Cannabis Medicines in the UK?

The UK’s Innovative Licensing and Access Pathway could help suitable cannabis medicines move from early clinical development towards licensing, NHS assessment and patient access. The next application round opens on 4 August 2026.

The UK medical cannabis sector has spent much of the past eight years operating within the unlicensed medicines framework.

This has created a lawful route through which specialist doctors can prescribe cannabis-based medicinal products when a patient’s clinical needs cannot be met by an appropriately licensed medicine. However, it has not created a straightforward pathway for those products to progress towards formal marketing authorisation, health technology assessment and routine NHS adoption.

The refreshed Innovative Licensing and Access Pathway, known as ILAP, may offer an important opportunity for developers that are ready to take that next step.

ILAP is not a general medical cannabis access scheme. It does not authorise an unlicensed product, provide prescriptions, guarantee NHS reimbursement or remove the need for clinical trials.

It is a coordinated development pathway for potentially transformative medicines that have reached a particular stage of clinical development. See Report Below

What is ILAP?

ILAP brings together the organisations responsible for medicines regulation, health technology assessment, clinical delivery and NHS adoption earlier in the development process.

The pathway includes the Medicines and Healthcare products Regulatory Agency, known as the MHRA, NICE, NHS England, the Scottish Medicines Consortium, the All Wales Therapeutics and Toxicology Centre and patient representatives.

Its entry point is the Innovation Passport.

A successful applicant then works with ILAP partners to produce a Target Development Profile. This is a living development roadmap that identifies the regulatory, clinical, evidence, market-access and NHS implementation issues that must be addressed as the medicine progresses.

Innovation Passport holders can also receive coordinated access to services including joint scientific advice, MHRA meetings, NICE advice, support with clinical trial delivery and planning for the eventual introduction of the medicine into standard patient care.

For developers, this joined-up approach could prevent a familiar problem: completing a clinical programme only to discover that the evidence does not meet the requirements of the MHRA, NICE or the health service that would ultimately need to deliver the treatment.

Why does ILAP matter to medical cannabis?

Most cannabis-based medicinal products prescribed in the UK remain unlicensed.

An unlicensed medicine can be supplied to meet the needs of an individual patient, but this route is not a substitute for pharmaceutical development. It does not, by itself, produce the evidence package required for a UK marketing authorisation or NHS assessment.

ILAP could provide a bridge between these two systems.

The current guidance specifically recognises that safety data collected when an unlicensed product has been administered outside a clinical trial, including as a special, may be considered as supporting evidence for an ILAP application.

This is potentially significant for cannabis oils and other cannabinoid medicines that already have documented human use. Patient treatment records, safety monitoring, prescribing histories and real-world outcomes may help establish an early evidence base.

However, patient experience alone will not make a product eligible. The evidence must relate to a real and identifiable medicine with an active development programme.

Clinical trials must be under way, preliminary human safety information must be available and the confirmatory trials intended to support the final marketing-authorisation application must not yet have started.

Which medical cannabis products may have the strongest case?

ILAP is intended for medicines addressing life-threatening or seriously debilitating conditions where there remains a significant unmet clinical need.

Applicants must also demonstrate that the product is innovative and has the potential to deliver a step change in patient outcomes or healthcare delivery when compared with the existing NHS standard of care.

For the cannabis sector, potentially relevant areas could include severe treatment-resistant epilepsy, rare neurological conditions, treatment-related symptoms or other clearly defined conditions where existing authorised treatments remain inadequate for a particular patient population.

For example, the existence of a licensed cannabidiol medicine does not necessarily mean that every patient with Dravet syndrome or another severe epilepsy has had their clinical need met.

A carefully defined cannabis oil might potentially be developed for patients who remain inadequately controlled, lose their response, cannot tolerate existing treatment or experience significant adverse effects.

The application would need to explain exactly which patients are being targeted, which treatments they have already received and how the proposed medicine could offer a major therapeutic advantage.

Who can apply?

ILAP applications can be made by commercial or non-commercial developers based in the UK or overseas.

Eligible applicants may include pharmaceutical companies, cannabis medicine manufacturers, universities, NHS organisations, charities, community interest companies and properly structured development consortia.

The applicant must be a legal entity and must hold the rights needed to develop and market the product in the UK. This could include rights relating to manufacturing, commercialisation, distribution, importation or intellectual property.

Clinics, pharmacies, specialist doctors, researchers and patient organisations can also play an important role in an application, even where they are not the lead applicant.

They may contribute clinical expertise, patient experience, real-world evidence, pharmacovigilance data, outcome-measure development, research capacity and support for clinical trial recruitment.

Who should apply?

The strongest candidates will be organisations that have progressed beyond a product idea and can demonstrate that a specific cannabis-based medicine is entering formal clinical development.

An organisation should consider applying where it has:

• legal control of a clearly defined finished medicinal product;
• preliminary evidence of safe use in humans;
• an active clinical trial or clinical-development programme;
• a specific indication and clearly identified patient population;
• evidence of a serious condition and significant unmet clinical need;
• a credible explanation of how the product could improve on existing NHS treatment;
• consistent pharmaceutical manufacturing and product specifications;
• the resources required to undertake further clinical development;
• a genuine intention to seek UK marketing authorisation and health technology assessment; and
• the ability to consider opening at least one clinical trial site in the UK.

A suitable candidate might be a pharmaceutical company, cannabis medicine manufacturer, university, NHS organisation, charity, community interest company or properly structured consortium.

For the medical cannabis sector, collaboration may provide the strongest model. A manufacturer or product owner could lead the application, supported by specialist clinicians, pharmacies, researchers and patient organisations contributing clinical expertise, patient insight, real-world evidence and trial-development support.

Organisations that have promising patient experience but have not yet completed the necessary product-definition, ownership, evidence and development work should undertake an ILAP feasibility assessment.

This can help identify whether a credible candidate exists and what must be completed before applying.

The central test is not whether a cannabis product is already prescribed or commercially available. It is whether the applicant can demonstrate that one defined medicine is ready for structured development towards UK authorisation and patient access.

A strategic opportunity for the UK sector

ILAP could provide the UK medical cannabis industry with an opportunity to move beyond indefinite reliance on unlicensed supply.

A successful programme could help transform a standardised cannabis formulation into a properly developed medicine supported by clinical evidence, regulatory approval, health-economic assessment and a potential NHS adoption pathway.

That would be important not only for manufacturers and investors, but also for prescribers and patients who need consistent products, reliable evidence and greater confidence in long-term access.

The opportunity is real, but it is narrow. It belongs to developers that are willing to define one product, address one clearly identified unmet need and undertake the clinical and pharmaceutical work required of any other medicine.