Right to Try 2026: What the UK’s New Clinical Trial Rules Mean for Access to Experimental Treatments

Written by Andrew Jones

Disclaimer: This article is for general information and educational purposes only. It does not constitute medical advice, legal advice, regulatory advice or a recommendation to participate in a clinical trial or use an unlicensed medicine. Experimental and unlicensed treatments may carry serious or unknown risks and may not provide any benefit. Patients should discuss their individual circumstances with a suitably qualified medical specialist. The information in this article is correct to the best of our knowledge as of 6 August 2026, but laws, clinical guidance and access pathways may change.

Faster Clinical Trials May Improve Access to Innovative Medicines, but Patients Do Not Have an Automatic Legal Right to Demand an Experimental Treatment

An Important Clarification About “Right to Try”

The phrase “Right to Try” can be misleading in the United Kingdom.

As of August 2026, the UK has not introduced a US-style law giving every patient with a serious, disabling or terminal condition an automatic legal right to obtain any experimental treatment they request.

The official UK policy called “Right to Try”, which came into effect on 30 April 2026, relates to disabled people and people with long-term health conditions trying to work or volunteer without that activity automatically triggering a reassessment of certain disability-related benefits. It concerns employment and social security protections, not access to experimental medicines.

The treatment-related legal development that came into force in April 2026 was the amended UK clinical trials framework. These reforms are intended to make clinical trials quicker and easier to establish while maintaining participant safety, ethical oversight and regulatory control.

Therefore, a more accurate description of the topic would be:

“The UK’s 2026 Clinical Trial Reforms and the Growing Opportunities to Access Experimental Treatments.”

What Changed on 28 April 2026?

The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 took full effect across the UK on 28 April 2026.

The changes represent the largest reform of UK clinical trial regulation in more than 20 years. They are designed to reduce unnecessary bureaucracy, speed up the approval of appropriate trials and encourage pharmaceutical companies and research organisations to conduct more medical research in the UK.

The reforms include:

Faster assessment of certain first-in-human trials.
A notification route allowing some lower-risk trials to begin sooner.
Quicker approval of eligible modifications to existing trials.
Greater use of suitable overseas safety data.
Recognition of computer modelling that may help predict how medicines behave before they are tested in people.
Stronger public transparency requirements.
Continued regulatory and ethical safeguards for participants.

Some qualifying modifications to trials may be approved through a faster process unless regulators raise concerns within the specified period. However, the reforms do not remove the responsibility to protect trial participants or demonstrate that the potential benefits justify the risks.

Greater Transparency for Patients and the Public

One of the most significant changes is the introduction of stronger legal transparency requirements.

Sponsors of clinical trials involving investigational medicinal products must register their trial publicly before recruiting the first participant or within 90 days of receiving approval, whichever occurs first. They must also report trial results and offer understandable summaries to participants or other relevant individuals.

This may help prevent important research findings from being hidden or left unpublished. It can also help patients, clinicians and researchers understand:

Which treatments have been investigated.
Whether a trial succeeded or failed.
What risks or side effects were identified.
Whether further research is planned.
How participants contributed to medical knowledge.

Plain-language summaries should take account of translation and accessibility needs. This is particularly important for people with cognitive impairments, learning disabilities, sensory impairments, neurological conditions or difficulties processing complex medical information.

Does the New Law Give Patients a Legal Right to Experimental Treatment?

No. The reforms do not allow a patient to demand a particular medicine simply because it is being studied or is available in another country.

Access may still depend on:

Whether an appropriate clinical trial exists.
The inclusion and exclusion criteria for that trial.
The patient’s diagnosis, age, medical history and previous treatments.
Whether participation would be considered reasonably safe.
The location of the research centre.
The willingness of the trial sponsor to supply the treatment.
Regulatory and research ethics approval.
The clinical judgement of the treating specialist.
NHS commissioning or funding arrangements.
Whether the pharmaceutical company operates an early-access programme.

Even where a patient is willing to accept considerable risk, a doctor, NHS organisation, research sponsor or pharmaceutical company cannot necessarily be compelled to provide an investigational medicine.

A “right to ask” is not the same as a legal right to receive the treatment.

What Is an Experimental Treatment?

An experimental treatment is generally a medicine, procedure, biological therapy, gene therapy or medical device that is still being investigated and has not yet gathered enough evidence for routine use.

An investigational medicine may still be undergoing research to establish:

The safest dose.
Potential side effects.
Whether it is more effective than existing treatments.
Which groups of patients are most likely to benefit.
How it interacts with other medicines.
Its longer-term risks.
Whether any improvements last.

An unlicensed medicine is not necessarily experimental in the same way. Some unlicensed medicines have been used for many years but do not hold a UK marketing authorisation for a particular formulation, age group or medical condition.

Similarly, an “off-label” medicine is normally licensed for one purpose but prescribed outside the precise terms of its licence. The NHS explains that a healthcare professional may recommend an unlicensed or off-label medicine when they believe it may treat the condition effectively and the potential benefits are greater than the risks.

Route One: Participating in a Clinical Trial

For many patients, the clearest route to a genuinely experimental treatment is through an authorised clinical trial.

Patients can ask their consultant, specialist nurse, GP or relevant patient organisation whether suitable studies are recruiting. The National Institute for Health and Care Research’s Be Part of Research service also allows people to search for and register an interest in health and care research taking place across the UK.

However, registering an interest does not guarantee acceptance. Every clinical trial has eligibility rules intended to protect participants and ensure that the study produces scientifically reliable results.

A person may be excluded because of another medical condition, previous treatment, medication interaction, pregnancy, infection risk, age range or the stage of their illness. Although exclusion can be distressing, it does not necessarily mean that the patient is being denied treatment unlawfully.

Route Two: The Early Access to Medicines Scheme

The UK already operates the Early Access to Medicines Scheme, commonly known as EAMS.

EAMS aims to provide patients with life-threatening or seriously debilitating conditions with access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.

Before access can be supported, the medicine normally goes through a two-stage process:

It receives a Promising Innovative Medicine designation.
The MHRA issues a positive EAMS scientific opinion after considering the available evidence and the medicine’s potential benefit-to-risk balance.

A positive scientific opinion can support a healthcare professional in prescribing the medicine. The pharmaceutical company or other holder of the EAMS opinion must also make the product available. Participation remains voluntary, and the EAMS process does not replace the normal medicines licensing procedure.

Consequently, EAMS is an important early-access route, but it is not an individual entitlement to any medicine a patient chooses.

Route Three: Unlicensed Medicines and “Specials”

UK legislation also allows certain unlicensed medicines, sometimes called “specials,” to be supplied to meet the special clinical needs of an individual patient.

These medicines must be ordered through an authorised prescriber, such as a doctor or another appropriately qualified independent prescriber. A supplier may also need evidence that a genuine special clinical need exists.

An unlicensed medicine should not normally be supplied merely because it is cheaper, more convenient or preferred by the patient when a suitable licensed product can meet the person’s clinical needs.

Prescribers may carry additional professional responsibility when recommending an unlicensed or off-label medicine. They must be satisfied that there is sufficient evidence or experience to justify its use and should explain the medicine’s status, possible risks and uncertainties to the patient.

Faster Licensing Does Not Mean Lower Safety Standards

The 2026 reforms are intended to make the regulatory system more proportionate, not to abolish safety checks.

The MHRA remains responsible for assessing whether the known and potential benefits of a medicine justify its risks. Research ethics committees also consider whether participants are properly informed, whether risks have been minimised and whether the research is ethically acceptable.

Alongside the clinical trial reforms, the MHRA and NICE introduced a more closely aligned pathway intended to bring certain regulatory and NHS access decisions together. The government states that this could help appropriate new medicines reach NHS patients approximately three to six months sooner. However, the MHRA and NICE continue to make separate decisions using their own regulatory, clinical and cost-effectiveness standards.

The Innovative Licensing and Access Pathway also aims to help developers bring potentially transformative medicines through regulatory and NHS assessment more efficiently. It includes organisations representing England, Scotland and Wales, but it does not guarantee that every medicine entering the pathway will eventually be licensed, recommended or funded.

Why This Matters to Disabled and Chronically Ill People

People living with rare diseases, progressive neurological conditions, advanced cancers, genetic disorders and treatment-resistant illnesses often face limited options.

For these communities, a faster clinical research system may provide:

Earlier opportunities to join trials.
Greater awareness of recruiting studies.
Faster evaluation of promising treatments.
Improved publication of trial results.
Better coordination between regulators and NHS decision-makers.
Increased investment in UK medical research.
More opportunities for patients to influence research design.

Nevertheless, accelerated systems must not create unrealistic hope. An investigational medicine may fail to work, cause serious side effects or make a person’s condition worse.

Access may also remain unequal. A patient who lives near a specialist research hospital may have opportunities that are unavailable to someone who cannot travel, needs personal assistance or lives in an area without a participating research centre.

Disability Access and Reasonable Adjustments

Clinical research must not become accessible only to people who can travel easily, use complex digital systems, understand lengthy documents or attend appointments without support.

Depending on the circumstances, reasonable adjustments may include:

Information in plain English or Easy Read.
Large-print, audio or accessible electronic documents.
British Sign Language interpretation.
Additional time to consider participation.
Allowing a support person, advocate or carer to attend discussions.
Accessible examination and treatment facilities.
Remote consultations where clinically appropriate.
Assistance with transport or appointment planning.
Written communication for people who cannot manage telephone calls.
Flexible appointment times for people affected by fatigue, pain or fluctuating conditions.

The Equality Act 2010 places duties on service providers to take reasonable steps where disabled people would otherwise experience a substantial disadvantage.

Article 25 of the United Nations Convention on the Rights of Persons with Disabilities also recognises the right of disabled people to access healthcare without discrimination and emphasises the importance of free and informed consent. These principles support equal access to healthcare and research, but they do not create an absolute right to receive an unproven medicine.

Informed Consent Must Remain Central

No person should be pressured into a clinical trial because conventional treatments have failed or because they fear losing their only opportunity.

Before agreeing to participate, the person should be given understandable information about:

The purpose of the research.
What treatment or procedures are involved.
Known and possible risks.
Potential benefits.
Alternative treatments.
The possibility of receiving a placebo or comparison treatment.
The number and location of appointments.
Additional tests, scans or hospital stays.
How personal data and samples will be used.
What happens if the treatment causes harm.
Whether expenses will be reimbursed.
What happens when the trial ends.

Informed consent remains a legal and ethical requirement. Participants must be able to ask questions and should be allowed sufficient time to consider the decision. A participant can generally withdraw from a clinical trial without giving a reason and without their decision affecting their ordinary clinical care.

Questions Patients May Wish to Ask

A patient considering an experimental treatment or clinical trial may wish to ask their specialist:

Is there reliable evidence that this treatment may help my particular condition?
What phase is the clinical trial in?
What is already known about side effects and long-term risks?
Could I receive a placebo or a different treatment instead of the experimental medicine?
Would I need to stop any of my existing medication?
How many appointments, tests or hospital stays would be required?
What reasonable adjustments and accessibility support are available?
Will travel, accommodation or care expenses be reimbursed?
What happens if my condition becomes worse?
Can I continue receiving the medicine after the trial ends?
Who is responsible for my treatment and monitoring?
What compensation or insurance arrangements apply if I am harmed?

Patients should be cautious of websites or individuals claiming that an overseas or unlicensed treatment is guaranteed to cure a serious condition. Desperation can make disabled and chronically ill people vulnerable to misleading marketing, unsafe imports and extremely expensive interventions unsupported by reliable evidence.

A Step Forward, but Not an Unlimited Right

The UK’s 2026 clinical trial reforms may help research begin more quickly, improve transparency and allow promising treatments to be evaluated sooner.

However, the reforms do not give patients an unrestricted legal right to demand an experimental treatment. Access continues to depend on clinical evidence, regulatory oversight, trial eligibility, informed consent, medical judgement, manufacturer participation and, in some cases, NHS funding.

For disabled people and those living with chronic or life-limiting illnesses, the greatest value of the reforms may be the opportunity for more research to take place in the UK and for patients to hear about suitable studies sooner.

The challenge will be ensuring that this progress is genuinely inclusive. Faster trials will mean little if disabled people are excluded by inaccessible information, rigid appointment systems, travel barriers, narrow eligibility criteria or a failure to provide reasonable adjustments.

Innovation must move quickly, but it must also remain safe, ethical, transparent and accessible to the people who need it most.