The bill bars civil and criminal liability for a medical practitioner—and the practitioner’s employer—who prescribes an unlicensed medicine or delivers a non‑standard treatment to a person defined as terminally ill, so long as the practitioner obtains informed consent, acts in good faith and reasonably believes the intervention may benefit the patient. It delegates definitions of “unlicensed medicine,” “non‑standard treatment” and “informed consent” to regulations made by the Secretary of State.
Separately, the bill requires the Secretary of State to make regulations permitting and facilitating the import, storage and use of equipment and unlicensed medicines specifically for treating people who are terminally ill. Regulations can be made by affirmative statutory instrument and may amend or repeal other Acts.
The measure extends to England and Wales and comes into force on enactment.
At a Glance
What It Does
The bill creates a conditional immunity from civil and criminal proceedings for practitioners and their employers when they prescribe unlicensed medicines or administer non‑standard treatments to patients the law defines as terminally ill, provided there is informed consent, good faith, and a reasonable belief of potential benefit. It also requires regulations to enable importation and storage of such medicines and equipment.
Who It Affects
Directly affects doctors and the organisations that employ them (for example NHS trusts and private clinics), suppliers and importers of unlicensed medicines and related equipment, and patients judged to be terminally ill under the bill’s 12‑month definition. Regulators (MHRA, CQC) and hospital procurement and legal teams will see practical downstream effects.
Why It Matters
By statutoryising a safe harbour and opening an import/storage route, the bill changes how access to experimental or off‑label treatments is delivered and governed in England and Wales — shifting decisions from regulators and courts toward ministers, clinicians and provider governance frameworks.
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What This Bill Actually Does
The bill creates a narrow statutory immunity that shields a medical practitioner and the practitioner’s employer from civil and criminal proceedings for actions connected to prescribing an unlicensed medicine or carrying out a non‑standard treatment for a patient who meets the bill’s definition of “terminally ill.” The immunity is conditional: the patient must give informed consent, the practitioner must act in good faith and have a reasonable belief that the action may benefit the patient. The statute does not itself define the key terms; the Secretary of State must provide those definitions by regulation.
On the supply side, the Secretary of State must make regulations permitting and facilitating the import, storage and use of unlicensed medicines and equipment when intended for treating people who are terminally ill. Those regulations will be the mechanism by which the government can specify controls — for example, who may import, storage conditions, record‑keeping and labelling — although the bill does not list those details and leaves them to ministerial rulemaking.The bill uses the affirmative parliamentary procedure for those regulations: a draft statutory instrument must be laid and approved by resolution of each House.
It also gives ministers express power to make consequential changes to other primary legislation, and permits regulations to amend or repeal Acts passed either before or later in the same parliamentary session. The Act applies to England and Wales and would commence on the day it receives Royal Assent.
The Five Things You Need to Know
The immunity covers both civil and criminal proceedings for the practitioner and the practitioner’s employer when the statutory conditions are met.
The bill defines “terminally ill” as a progressive disease where death from that disease can reasonably be expected within 12 months.
The Secretary of State must define by regulation the terms “unlicensed medicine,” “non‑standard treatment” and “informed consent.”, Regulations must permit import and storage of unlicensed medicines and equipment specifically for treating people who are terminally ill, creating a ministerial pathway for supply.
Any regulations are made by statutory instrument and require prior laying and approval by resolution of both Houses of Parliament; regulations may also amend or repeal other Acts.
Section-by-Section Breakdown
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Conditional immunity for practitioners and employers
Section 1 establishes the core safe harbour. It immunises a medical practitioner and their employer from civil and criminal proceedings for actions connected to prescribing an unlicensed medicine or providing a non‑standard treatment, provided four conditions are met: the recipient is ‘terminally ill’ under the bill’s 12‑month test, the patient has given informed consent, the practitioner acts in good faith and reasonably believes the action may benefit the patient. The practical effect is to shift some legal risk from individual doctors and trusts to the institutional and regulatory settings that determine what counts as consent, unlicensed and non‑standard — all of which the Secretary of State must define by regulation.
Regulatory duty to enable import, storage and use
Section 2 requires the Secretary of State to make regulations that permit and facilitate importing, storing and using unlicensed medicines and equipment when intended for treating terminally ill people. The provision is permissive and enabling rather than prescriptive: it obliges ministers to create a legal pathway but does not prescribe operational controls (for example, who may import, licensing of importers, supply chains, or record‑keeping). Those operational details will be set in secondary legislation or guidance, not the Act itself.
Wide regulatory powers and parliamentary approval
Section 3 authorises use of statutory instruments to implement the Act and gives ministers power to amend or repeal other primary legislation by regulation, including Acts passed before or later in the same session. Importantly, it requires that any statutory instrument under the Act be laid in draft and approved by resolution of both Houses — an affirmative procedure that gives Parliament a formal veto over the content of those regulations.
Extent, commencement and short title
Section 4 limits territorial extent to England and Wales, sets commencement on the day the Act is passed, and provides the short title. The territorial scope excludes Scotland and Northern Ireland, meaning any changes to supply chains, regulator interactions, or clinical governance within NHS Scotland or Northern Ireland would remain governed by devolved arrangements unless separate measures are taken.
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Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- People judged terminally ill (as defined by the bill): gain a clearer legal route to access unlicensed or non‑standard treatments and equipment that clinicians and suppliers make available under the statutory pathway.
- Medical practitioners: receive statutory protection from civil and criminal proceedings when they meet the bill’s conditions, reducing legal risk around compassionate‑use decisions.
- Employing organisations (NHS trusts and private clinics): benefit from employer immunity, which lowers institutional litigation exposure tied directly to clinician decisions covered by the Act.
- Importers and suppliers of unlicensed medicines and equipment: gain a ministerially authorised channel for importation and storage specifically tied to terminal care, potentially opening new supply opportunities.
Who Bears the Cost
- MHRA and other regulators: may face operational and resource pressure to adapt oversight, inspections and guidance to a new ministerial pathway for unlicensed products, without the bill specifying resourcing.
- NHS trusts and procurement/legal teams: must design and operate governance, consent and storage procedures to rely on the statutory immunity, incurring administrative, training and possibly insurance‑related costs.
- Patients and families: bear clinical risk from treatments that have not passed standard regulatory approval; proving that consent was informed and that clinicians acted in good faith will be litigated if disputes arise.
- Insurers and indemnity providers: may need to reassess cover terms and premiums for practitioners and employers operating under the new regime, shifting costs into commercial pricing or exclusions.
Key Issues
The Core Tension
The bill balances two legitimate aims—speeding patient access to potentially beneficial unlicensed interventions at the end of life, and preserving patient safety through regulatory oversight—but solving one weakens the other: statutory immunity and a ministerial import route increase access and clinician autonomy while delegating oversight to regulation and provider governance, which may reduce independent scrutiny and create uneven protections for patients.
The bill leaves critical details to secondary legislation and guidance, which is efficient but concentrates substantive choices — definitions, eligibility criteria, import controls, record‑keeping and oversight — in the hands of ministers rather than Parliament or regulators. That raises implementation risks: without minimum statutory safeguards (for example mandatory reporting, independent review or data collection) there is a danger of inconsistent practice across providers and gaps in patient safety monitoring.
The affirmative SI procedure gives Parliament a say, but the initial regulatory design will determine how safe and workable the pathway is in practice.
Another unresolved question is the bill’s relationship with existing criminal offences and professional standards. The immunity bars civil and criminal proceedings where its conditions are met, but it does not say how it interacts with offences such as gross negligence manslaughter or deliberate harm, nor with professional disciplinary processes that set competency and safety standards.
Practically, disputes will shift toward proving whether the statutory conditions—particularly informed consent, good faith and reasonable belief of benefit—were satisfied, placing a heavy evidential weight on documentation and local governance systems. The Act also confines itself to England and Wales, which complicates supply chains and cross‑jurisdiction clinical practice for providers operating UK‑wide.
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