How an Australian Patient Joined an Israeli Trial After a Refusal

Result: Enrolment approved after an initial screening refusal, with the hospital's open-ended financial undertaking capped · Timeline: 5 months from first contact to first dose · Challenge: Trial site refused a participant living 14,000 km away · Authority: Institutional Helsinki Committee and the Ministry of Health · Financial Impact: NIS 38,400 charged against a capped NIS 120,000 guarantee

Background

A man in his fifties in Melbourne had run out of standard options for a rare soft tissue sarcoma. His Australian oncologist said so plainly and suggested the family look at trials. His daughter found a phase two study running at a Tel Aviv medical centre, emailed the research coordinator, and received a reply within two days declining to pre-screen him. The reasons given were that the protocol required weekly safety visits through the first two cycles, that participants needed a named treating physician in Israel, and that the centre could not enrol a patient with no Israeli health cover.

The family read that as a legal bar on foreigners. It was not. Nothing in Israeli clinical trials law turns on where a participant lives, and the coordinator had not refused on nationality grounds. She had refused on three operational grounds, each of which was capable of being answered. The difficulty was that answering them required work at the hospital, at the ethics committee and at the immigration authority, in that order, and none of it would happen in response to emails from Australia.

The Challenge

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 requires approval from the institutional Helsinki Committee, the ethics body at the hospital where it runs, and from the institution's director. Trials outside the "special" classification also require the approval of the Director General of the Ministry of Health. The principal investigator must hold an Israeli medical licence. None of that framework asks about residence. What excludes non-residents is the individual protocol, and here the protocol demanded weekly bloods and imaging at the site through two cycles, which no one can supply from Victoria.

Money was the second obstacle and the more dangerous one. The sponsor pays for the investigational product and for procedures the protocol requires. Everything around it is ordinary medical care, and Section 3(a) of the National Health Insurance Law 5754-1994 ties entitlement to Israeli public health cover to residency rather than citizenship, so a visiting Australian has none. Scans outside the protocol, an admission for a complication, supportive treatment, all of it is billed at the Ministry of Health's non-resident tariff and demanded in advance. Australia does not help here. Medicare pays nothing for care received overseas, Israel is not one of the countries covered by Australia's reciprocal health care agreements, and the family's travel policy excluded both experimental treatment and pre-existing conditions.

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 not classified as special, and consent must satisfy Section 13 of the Patient Rights Law 5756-1996, which requires an explanation in a language the patient actually understands. Screening to first dose commonly runs 4 to 10 weeks. A protocol amendment or a documented accommodation for an overseas participant adds 6 to 12 weeks at committee; in this file the committee took 7 weeks.

What We Did

The first step was to read the protocol rather than the rejection email. We asked the site for the inclusion and exclusion criteria and went through them line by line. Residence appeared nowhere. What appeared was a requirement for a treating physician at the site and a visit schedule, both of which are logistical conditions rather than eligibility criteria, and both of which can be satisfied by a patient who is physically in Israel during the intensive phase.

So we rebuilt the application around that. The family rented an apartment twenty minutes from the medical centre for an initial ten weeks. We identified an Israeli-licensed oncologist already working with the centre who agreed to act as the named treating physician between site visits, and obtained a written co-management arrangement with the Melbourne oncologist covering imaging transfer, adverse event reporting and the handover back to Australia at the end of the intensive phase. That document did more than anything else to change the coordinator's answer, because it removed the site's real fear, which was clinical responsibility for a patient who would disappear onto a plane.

Immigration came next and had to be prepared before departure rather than after arrival. A B/2 visitor entry does not accommodate a twelve month treatment schedule, and applications made from inside Israel after the initial period expires are decided far less generously than those supported in advance. We assembled a letter from the medical centre confirming the treatment plan and its expected duration, evidence of funds, and the accommodation contract, and filed for an extension of stay with the Population and Immigration Authority under the Entry into Israel Law 5712-1952. His wife travelled as a companion on the same evidence rather than as an afterthought.

The financial undertaking was where we spent the most time and saved the most money. The centre presented two documents on the same day: the informed consent form governed by Section 13 of the Patient Rights Law 5756-1996, and a separate financial undertaking. The second is not a research document at all. It is a commercial contract, it sat outside the sponsor's trial insurance, and as drafted it made the patient liable without limit for any care the protocol did not cover, including an intensive care admission arising from a trial-related complication. We negotiated three changes. The sponsor's obligations were listed in writing rather than assumed. Complications attributable to the investigational product were carved out and directed to the sponsor and its insurer. The residual exposure was capped at NIS 120,000, secured by a bank guarantee instead of a cash deposit, so the money stayed in Australia earning interest until it was called.

The site then took the accommodation plan, the co-management letter and the revised undertaking to the Helsinki Committee. Approval came back in seven weeks. Screening ran three weeks after that and the first dose followed.

In Practice: Because Section 3(a) of the National Health Insurance Law 5754-1994 excludes non-residents from public cover, every service 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. Over eight months this patient was charged NIS 38,400 in non-protocol care against the capped NIS 120,000 guarantee, and the two nights he spent as an inpatient after a protocol-related reaction were billed to the sponsor rather than to him.

The Outcome

He received his first dose five months after the coordinator's refusal, and completed the intensive phase in Israel before moving to a monthly schedule that his Melbourne oncologist supervised with quarterly flights to Tel Aviv. The disease response is his and his doctors' business rather than ours. What the legal work produced was access on terms that did not put the family's house behind it: a NIS 120,000 ceiling instead of unlimited liability, a bank guarantee instead of a deposit, and NIS 38,400 of actual charges over eight months.

Planning the exit mattered as much as the entry. Continuing the drug in Australia after the trial ends is not automatic and is not a class entitlement. It requires his Australian prescriber to apply to the Therapeutic Goods Administration under the Special Access Scheme for each supply, with the manufacturer's agreement, decided patient by patient. We raised that with the sponsor at the point of enrolment rather than at the end, and the sponsor's written willingness to supply on request is now on the file. Families who leave that question to the final visit frequently find the answer is no.

Key Takeaways

What this case illustrates for non-residents in similar situations:

1. A refusal from a research coordinator is rarely a legal refusal. Israeli clinical trials law under the Public Health Regulations (Clinical Trials in Human Subjects) 5741-1980 does not ask where a participant lives. Ask for the protocol's actual inclusion and exclusion criteria and see whether residence appears in them, because usually it does not.
2. Solve the site's clinical anxiety before asking it to solve yours. A named Israeli treating physician, a written co-management arrangement with the doctor at home, and accommodation near the site convert an impossible participant into an ordinary one.
3. The consent form and the financial undertaking are different animals. The first is governed by Section 13 of the Patient Rights Law 5756-1996. The second is a commercial contract with no statutory protection, it is negotiable, and an uncapped version is the single largest financial risk in the file.
4. Fix immigration status before the flight. An extension of stay supported by a hospital letter, an accommodation contract and proof of funds is a different application from one made after a visitor entry has run out, and companion status for a spouse is not automatic.
5. Ask about post-trial supply on day one. Continuation in Australia runs through the Therapeutic Goods Administration's Special Access Scheme and depends on the manufacturer agreeing, which is far easier to secure while you are still a participant the sponsor wants. Our note on bringing and continuing prescription medication in Israel covers the parallel problem in the other direction.

---

Facing a Similar Situation?

If an Israeli hospital has told you that a trial is closed to you because you live overseas, the useful question is which of the three usual obstacles is actually in the way: the visit schedule, the absence of a local physician, or the absence of health cover. Each has a different answer, and our response on joining an Israeli clinical trial as a non-resident sets out the framework in full.

Contact us for a confidential consultation about your Israeli legal matter.