Medical freedom / M3
Experimental drug for the dying
A terminally ill patient wants a drug that has passed Phase 1 trials but is not approved anywhere, and the manufacturer is willing to supply it.
What we score
Can the patient get it?
Default assumptions: Unless a vignette says otherwise, the person is a 30-year-old citizen of sound mind with no criminal record, acting alone, on their own behalf and not for profit, in an ordinary residential area. Where subnational units (states, provinces, cantons, Länder) make their own law, each unit is scored and the result is weighted by population. 'The state' includes police, prosecutors, courts, regulators, tax authorities and anyone acting on their orders, including platforms obeying takedown orders.
Score anchors
Both the law score and the practice score use these anchors. Half points are used when a country sits between two of them.
| Score | What it means for this vignette |
|---|---|
| 10 | Patient and manufacturer may contract directly. |
| 8 | Right-to-try: lawful with notification only. |
| 6 | Expanded-access or compassionate-use scheme on objective criteria. |
| 4 | Discretionary regulator approval, rarely granted or slow. |
| 3 | No lawful route; administrative penalties. |
| 2 | No lawful route; crime for supplier or patient. |
Evidence used: Right-to-try law; expanded-access and compassionate-use rules; approval rates and timelines.
How each country scores
| Country | Law | Practice | Process | Score | Why |
|---|---|---|---|---|---|
| United States | 8 | 8 | 0 | 8.0 | The federal Right to Try Act (2018) lets a terminally ill patient who has exhausted approved options get a drug that has passed Phase 1 directly from a willing manufacturer. The FDA does not approve individual requests; its role is limited to receiving annual reports. FDA expanded access is another route with near-universal approval. With a willing manufacturer, access is effectively by notification. |
| New Zealand | 8 | 7 | 0 | 7.4 | Medicines Act s29 lets a medical practitioner, nurse practitioner or pharmacist prescriber obtain any unapproved medicine, including one approved nowhere, for a patient under their care, with the supply reported to the Director-General rather than approved in advance. So a dying patient with a willing manufacturer and a willing doctor can get a post-Phase-1 drug without regulator permission. Access in practice depends on finding a doctor willing to take clinical responsibility. |
| Switzerland | 7 | 6 | 0 | 6.4 | Swissmedic may temporarily authorise use of unapproved medicines for life-threatening diseases outside trials (Therapeutic Products Act Art. 9b(1)). A treating doctor may import small quantities of a drug authorised for clinical trials in a comparable country for a specific patient after filing a risk analysis with the canton (AMBV Art. 49(2)). That route works on notification but depends on the drug being in a recognised trial. |
| Germany | 6 | 6 | 0 | 6.0 | Compassionate use (§ 21(2) Nr. 6 AMG and the Arzneimittel-Härtefallverordnung) lets an unapproved drug be supplied free of charge to patients with a life-threatening or seriously debilitating disease. The drug must be in clinical trials or under an approval application, and cohort programmes need confirmed notification to BfArM/PEI. Individual named-patient use falls outside the AMHV. |
| Singapore | 6 | 6 | 0 | 6.0 | HSA's Special Access Route lets a licensed hospital, clinic or pharmacy import an unregistered drug, including an investigational one, for a named patient. The conditions are that the therapy is life-saving, there is an unmet need, and the applicant supplies documentary proof of professional consensus. HSA targets 14 working days and does not assess efficacy; the clinician bears full responsibility. The patient cannot contract directly with the manufacturer. |
| Denmark | 6 | 6 | 0 | 6.0 | Under § 29 of the Medicines Act, a doctor can apply to the Danish Medicines Agency for a named-patient permit (udleveringstilladelse) for an unauthorised medicine, including experimental drugs made by a pharmaceutical company; general permits covering several patients also exist. Patients cannot apply themselves, and the agency decides case by case. I found no published approval rates. |
| Netherlands | 6 | 5 | 0 | 5.4 | Art. 40(3) Geneesmiddelenwet allows compassionate-use programmes (CUPs) approved by the medicines board (CBG) on set criteria: a serious or life-threatening disease, no adequate registered treatment, and a pending authorisation application or ongoing trials. Single patients can also be supplied on a named-patient basis through the IGJ. Both routes depend on the manufacturer applying and on regulator approval. |
| United Kingdom | 6 | 5 | 0 | 5.4 | There is no right-to-try law. A doctor can prescribe an unapproved drug on a named-patient basis under the 'specials' exemption (Human Medicines Regulations 2012 reg 167), on their own clinical responsibility, if the manufacturer will supply it. The MHRA's Early Access to Medicines Scheme gives cohort access only after a discretionary 'promising innovative medicine' designation and scientific opinion. NHS funding and the willingness of doctors and trusts are practical bottlenecks. |
| Czechia | 5 | 5 | 0 | 5.0 | A drug registered nowhere cannot be prescribed under § 8(3), which requires foreign registration. The route is a specific treatment programme (Medicines Act § 49) proposed by the manufacturer or a doctor, approved by the Ministry of Health after a SÚKL opinion, for conditions seriously threatening health. Approval is discretionary but programmes are routinely approved. EU-level compassionate use under Reg. 726/2004 art. 83 also applies. |
| Mexico | 5 | 5 | 0 | 5.0 | LGS art. 103 lets a treating physician use investigational therapies when there is a 'posibilidad fundada' of saving life or reducing suffering, with the patient's written consent. Mexico has no right-to-try statute or formal expanded-access scheme. Importing an unregistered product requires a COFEPRIS permit (Reglamento de Insumos art. 196), which COFEPRIS grants case by case, so access depends on regulator discretion and paperwork. |
| Ireland | 5 | 4 | 0 | 4.4 | Ireland has no right-to-try law and no national compassionate-use scheme. The HPRA lists two routes before authorisation: clinical trials, and exempt medicinal products, which it describes as medicines authorised abroad that a prescriber orders for a patient under their responsibility. A drug unapproved anywhere therefore depends on a trial place, an EMA-coordinated compassionate-use programme or a manufacturer's named-patient supply that the doctor is willing to prescribe. Funding and hospital approval are further bottlenecks. |