How a UK Patient Obtained an Unregistered Drug for Treatment in Israel

Result: Ministry of Health approval for an unregistered targeted therapy in 26 days, under a capped treatment contract · Timeline: 4 months from instruction to the first cycle · Challenge: Drug not registered in Israel and NHS funding refused · Authority: Ministry of Health Pharmaceutical Division · Financial Impact: NIS 412,000 contract capped, NIS 78,000 refunded

Background

A man in his late fifties from Leeds was diagnosed with a rare soft-tissue sarcoma in late 2025. His oncologist identified a targeted therapy licensed in the United States and the European Union that fitted the tumour's molecular profile, and applied for NHS individual funding. The application was refused. A cousin in Ra'anana suggested an Israeli medical centre with a sarcoma unit, and by February 2026 the patient had a written treatment proposal from its international patient department and was preparing to fly.

He came to us because of the money. What he needed help with turned out to be something else entirely. Nobody had told him that the therapy his Israeli oncologist proposed to give him is not registered in Israel either, and that the route to putting it into his arm runs through the Ministry of Health rather than through the hospital.

The Challenge

Israel maintains its own medicines register, and a preparation licensed by the FDA or the EMA has no automatic standing here. Supply of an unregistered preparation is governed by Regulation 29 of the Pharmacists (Preparations) Regulations 1986, which carves out narrow routes for exactly this situation: compassionate use, named-patient supply, hospital use, and personal import by a traveller.

Two features of that regime shaped the entire case. The first is that the patient cannot be the importer. Where an unregistered preparation is to be administered in an Israeli hospital, the import must be made by a licensed pharmacy or by the holder of an importer or manufacturer licence, which in practice means the hospital's own pharmacy. Our client had been quietly assuming he could buy the drug in England and carry it with him. Had he done so, the hospital pharmacy would have refused to administer it, and he would have arrived in Israel with an expensive box nobody could lawfully hang on a drip stand.

The second is that approval is not automatic. The treating physician must apply to the Ministry of Health on the designated form, and the substantive test is that the treatment is essential for this patient and that no registered, marketed alternative exists in Israel for the same purpose. That is a real threshold. An application that fails to address why the registered alternatives were rejected for this particular tumour comes back with questions, and every round trip costs weeks a sarcoma patient does not have.

Sitting behind both of these was a third problem the patient raised almost as an afterthought, on the way out of the meeting. He was taking a strong opioid analgesic for pain control and had assumed he would simply pack three months of it.

In Practice: Under Regulation 29 of the Pharmacists (Preparations) Regulations 1986, an unregistered preparation may be imported and supplied for a named patient only by a licensed pharmacy or a licensed importer, and only where the treating physician's application satisfies the Ministry of Health that the treatment is essential and that no registered, marketed alternative exists in Israel for the same purpose. The physician files the designated Ministry of Health form, Form 4 for compassionate use or emergency treatment of an individual patient, through the Ministry's online system, and the institution must meet the quality assurance requirements set out in Ministry of Health Circular DR-129 for institutional and individual import. A complete first-time application for an oncology preparation is typically decided in 3 to 6 weeks. An incomplete one adds a further 2 to 4 weeks per round of queries.

What We Did

We split the work into the regulatory track and the commercial track, and ran them in parallel, because the hospital would not start the first until it had comfort on the second.

The regulatory track. We met the Israeli treating oncologist and the hospital's chief pharmacist together, which is not the usual order of business but saved a month. The application under Regulation 29 belongs to the physician and the pharmacy, not to the lawyer or the patient, so our contribution was evidential rather than legal: we assembled the English pathology report, the molecular profiling, the NHS individual funding refusal with its stated reasons, and a letter from the UK oncologist explaining which registered agents had been considered and why each was unsuitable. The refusal letter turned out to be the most useful document in the bundle. It set out, in the NHS's own words, that the patient's tumour type fell outside the licensed indications of every routinely commissioned agent, which is close to the exact question the Israeli file had to answer.

The pharmacy filed in March 2026. The Ministry of Health approved in 26 days with no queries.

The consent documents. Section 13 of the Patient Rights Law 1996 requires informed consent based on the information a reasonable patient would need, and Section 14 requires that consent for listed procedures be given in writing. Where the preparation is not registered in Israel, that fact belongs in the consent form, and so does the regulatory basis on which it is being supplied. The hospital's standard oncology consent form said neither. We asked for both to be added and for the whole document to be provided in English rather than a verbal translation at the bedside. The hospital agreed without argument. Patients rarely ask for this, and in our experience hospitals rarely refuse when they do.

The pain medication. This was the piece that nearly went wrong at the airport. Regulation 29 permits a traveller to bring a personal supply of a medicine into Israel for their own use, capped at 60 days, and only where the medicine is registered and marketed in the country it came from, was bought from an authorised pharmacy, and is not a dangerous drug. His analgesic is scheduled under the Dangerous Drugs Ordinance [New Version] 1973, which puts it outside the personal import route entirely. He needed a separate Ministry of Health import permit, obtained in advance, and he had to declare the medicine at Ben Gurion rather than walk it through the green channel. We applied for the permit in the same week the hospital filed its Regulation 29 application, and it issued in eleven days.

The commercial track. The treatment proposal was a range rather than a price, which is normal in oncology and unhelpful in a contract. We converted it into a written agreement with three features the original draft lacked: a per-cycle price rather than a protocol price, a cap on the institutional handling margin applied to the drug's acquisition cost, and an express refund of the deposit balance for any cycle not administered. The deposit was NIS 180,000 against a capped total of NIS 412,000. His UK travel policy excluded planned treatment abroad, as most do, but a private medical policy he had held for years paid a partial reimbursement once we obtained the itemised bill in English with the treatment codes spelled out.

In Practice: Regulation 29 of the Pharmacists (Preparations) Regulations 1986 allows a traveller to bring in a personal supply of up to 60 days of a medicine that is registered and marketed in the source country and bought from an authorised pharmacy, but expressly excludes preparations classified as dangerous drugs. A controlled analgesic scheduled under the Dangerous Drugs Ordinance [New Version] 1973 therefore requires a Ministry of Health import permit obtained before travel and a declaration at the border, which takes around 2 weeks to issue. A patient who arrives without it faces seizure of the medicine at Ben Gurion and, in this case, would have paid roughly NIS 4,200 to replace a month's supply privately in Israel while a fresh prescription and permit were arranged.

The Outcome

The first cycle was administered in April 2026, four months after the patient first contacted us and about six weeks after the Israeli hospital's file was opened. The Ministry of Health approval under Regulation 29 came through in 26 days, which is at the fast end of the range and reflects a complete application rather than any special treatment. The protocol was reduced from six cycles to four on clinical review after imaging, and because the contract priced cycles individually with a refund mechanism, NIS 78,000 of the deposit came back rather than being absorbed into a protocol fee. The itemised English invoice supported a partial reimbursement from his private medical insurer in the UK.

The patient's own summary, offered several months later, was that the drug was never the hard part. What nearly derailed the treatment was a set of assumptions that would have been correct almost anywhere else: that a drug licensed in Europe can be carried across a border, that a hospital can give a patient whatever the patient has paid for, and that a strong painkiller is a private matter between a patient and a prescriber.

Key Takeaways

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

1. A licence from the FDA or the EMA means nothing to an Israeli hospital pharmacy. If the preparation is not on the Israeli register, supply runs through Regulation 29 of the Pharmacists (Preparations) Regulations 1986, and the application belongs to the treating physician and a licensed pharmacy, never to the patient.
2. Do not buy the drug abroad and bring it for hospital administration. The importer must be a licensed pharmacy or licensed importer, and an unregistered preparation carried in by the patient cannot lawfully be given on the ward.
3. A home-country funding refusal is an asset, not an embarrassment. A commissioning body's written reasons for rejecting the registered alternatives address almost exactly the question the Israeli application has to answer, so ask for the refusal letter in full and put it in the bundle.
4. Check your regular medication against the Dangerous Drugs Ordinance before you fly. The 60-day personal import allowance does not extend to controlled substances, and the Ministry of Health permit takes around two weeks, so it has to be started well before the flight is booked.
5. Price oncology by the cycle, with a written refund of any unused deposit balance. Protocols get shortened as often as they get extended, and a per-protocol fee gives the hospital no reason to return anything.

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Facing a Similar Situation?

If you are arranging treatment in Israel that depends on a medicine not registered here, the regulatory pathway needs to start before you book a flight, not after you arrive. The same applies where a home-country insurer or health service has refused funding and you are self-paying, because the terms of the hospital contract then carry the whole risk. Our guide to cancer treatment in Israel for non-resident patients covers deposits, payment guarantees and medical records, and we set out the traveller rules in bringing prescription medication into Israel.

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