I live in Canada. Can I join a clinical trial at an Israeli hospital?

Families in Toronto and Montreal usually arrive at this question the same way. A Canadian oncologist says the options are exhausted, somebody finds an Israeli phase two study online, and the assumption is that the barrier will be legal. It rarely is. Israeli law is close to silent on where a trial participant lives, and the real obstacles are the protocol, the follow-up schedule and who pays for everything the trial does not.

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Detailed Answer

Clinical research in Israel runs under the Public Health Regulations (Clinical Trials in Human Subjects) 5741-1980 together with the Ministry of Health's Clinical Trials Guideline No. 14. Every trial needs the approval of the institutional Helsinki Committee, the ethics body at the hospital where it will run, and the approval of the institution's director; trials that are not classified as "special" also require the approval of the Director General of the Ministry of Health. The principal investigator must be a physician licensed in Israel, and the study must be registered before recruitment. None of that turns on the participant's nationality or residence. What does exclude non-residents is written into the individual protocol: inclusion criteria commonly require a named local physician, laboratory and imaging at the trial site on a fixed schedule, and an ability to attend for safety visits at short notice. A study demanding weekly bloods for the first two cycles is not compatible with flying in from Ontario, and the site will say so at screening rather than at the ethics committee. Consent is governed by Section 13 of the Patient Rights Law 5756-1996, which requires informed consent given after an explanation in a language the patient understands, so the site must provide the consent form in a language you actually read, and in practice English versions exist at all the major centres.

Money is where Canadians get caught. The sponsor covers the investigational product and the procedures the protocol requires, but standard care around it is not covered, and Section 3(a) of the National Health Insurance Law 5754-1994 makes entitlement to Israeli public health cover a matter of residency, which a visiting Canadian does not have. Scans, admissions, supportive treatment and any complication are billed at the Ministry of Health's non-resident tariff and demanded up front. Provincial plans do not fill that gap: OHIP and RAMQ pay little or nothing for care received abroad, and travel policies exclude experimental treatment and pre-existing conditions almost universally. Immigration status is the second trap, since a B/2 visitor entry does not stretch to a twelve month treatment schedule, an issue our answer on continuing medical treatment in Israel after a tourist visa expires sets out. Plan the exit too. If the drug works, continuing it in Canada means your Canadian physician applying to Health Canada's Special Access Programme for each individual supply, which requires the manufacturer's agreement and is decided patient by patient rather than granted as a class.

In Practice: Enrolment is approved by the institutional Helsinki Committee under the Public Health Regulations (Clinical Trials in Human Subjects) 5741-1980, with the Director General of the Ministry of Health also approving trials that are not classified as special; consent must satisfy Section 13 of the Patient Rights Law 5756-1996. Screening to first dose typically runs 4 to 10 weeks, and a protocol amendment to accommodate an overseas participant adds 6 to 12 weeks at committee. Because Section 3(a) of the National Health Insurance Law 5754-1994 excludes non-residents, everything outside the protocol is charged at the Ministry of Health's overseas tariff, commonly NIS 6,000 to NIS 10,000 per inpatient day and NIS 1,200 to NIS 2,500 for an outpatient specialist attendance, payable in advance or against a guarantee.

When to Consult a Lawyer

• The hospital asks you to sign a consent form and a separate financial undertaking on the same day. The second document is a commercial contract with an open-ended liability for complications, and it is not covered by the sponsor's trial insurance.
• You are travelling with a relative who will need to stay for months as a carer. Companion status is not automatic on a visitor entry, and applications made after arrival are decided far less favourably than those prepared before you fly.
• An adult patient may lose capacity during treatment. A Canadian power of attorney for personal care is not self-executing in an Israeli hospital, and substitute decision-making has to be arranged under Israeli law before it is needed.

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Speak With an Israeli Attorney

We review the consent and financial undertaking before you sign, confirm what the sponsor is actually paying for, and put the visa and decision-making documents in place so a treatment plan is not interrupted by an immigration or capacity problem.

Contact us for a confidential initial consultation.