Annual Donation Reporting Obligation – Section 40A, National Health Insurance Law
Under Section 40A of the National Health Insurance Law, 1994, donation reporting obligations must be met by March 1, 2025. Both donors and recipients in the healthcare sector are required to report contributions to the Ministry of Health.
Key reporting obligations include:
- Who Must Report?
- Any donor contributing to an entity operating in healthcare.
- Any donation exceeding 2,500 NIS to physicians, pharmacists, or medical researchers.
- Recipients must disclose the donor’s identity and the donation’s purpose.
- What Qualifies as a Donation?
- Financial or non-monetary contributions.
- Clinical research agreements and consultancy payments are not considered donations and are exempt from reporting.
- Conference Sponsorships & Compliance Risks:
- Participation fees and exhibitor payments are considered commercial transactions.
- Sponsorships (e.g., logo placement) may be deemed donations and should be reported to mitigate compliance risks.
Organizations should review their records to ensure accurate reporting and avoid discrepancies with Ministry of Health records.
Procedure 176/01 – Remote Access to Medical Records in Clinical Research
The Ministry of Health’s Pharmacy Division has published Procedure 176/01, titled “Remote Access for Data Verification in Medical Research“, set to take effect in June 2025.
This procedure establishes the conditions for granting direct remote access to the medical records of clinical trial participants, facilitating Source Data Review (SDR) and Source Data Verification (SDV) in compliance with Good Clinical Practice (GCP) standards. The procedure assigns responsibility to medical institutions managing patient records, granting them the authority to approve access under specified conditions.
Although the procedure takes effect in June 2025, pharmaceutical companies planning to implement remote access should begin preparing now. This includes engaging in a professional dialogue with the medical institutions where they conduct clinical trials to explore available options for implementing these procedures. Additionally, companies should assess their eligibility, establish the necessary contractual agreements, and ensure compliance with regulatory requirements to facilitate a smooth transition.
Amendment to the Controlled Substances Regulations, 1980
In January 2025, the Knesset Health Committee approved a significant amendment to the Controlled Substances Regulations, 1980,[“סמים מסוכנים”] revising prescription guidelines and tightening oversight on opioid prescriptions to mitigate misuse.
Companies should carefully assess how this regulatory change affects their Market Access strategy for the pharmaceuticals they market.
Concurrently, the amendment introduces limited flexibility, allowing certain medications, such as those for ADHD, narcolepsy, and eating disorder, to be prescribed for two months—albeit with more restrictions than previously proposed drafts.
The key regulatory modifications include:
- Prescription Validity: While the standard prescription validity remains 15 days, controlled substances listed in Schedule Six are now restricted to a 5-day validity period.
- Duration of Treatment: The framework allowing a 10-day treatment period remains unchanged, while 31-dayprescriptions remain permissible. Additionally, an extended 62-day prescription period is authorized for ADHD, narcolepsy, and binge-eating disorder treatments.
- Electronic Prescriptions via HMOs: Controlled substance prescriptions must now be issued exclusively as electronic prescriptions through HMOs, with limited exceptions for home care, drug rehabilitation, and military veteran treatments.
- Exception to HMO Electronic Prescription Requirement: A notable exception to the requirement for electronic prescriptions issued exclusively through HMOs applies when a pharmacist has access to an HMO’s computerized system and receives a negative confirmation regarding the prior dispensation of Schedule Six controlled substances (31 days). In such cases, non-electronic prescriptions may also be issued, however they will be limited to a 5-day validity period and a 5-day treatment supply.
- Maximum Dosage Limits: Remain unchanged, with exemptions still in effect for critically ill patients.
The final version of the regulations is pending official publication, and changes may still be introduced.
New Expedited Medicinal Products Registration Pathways
In January 2025, the Department of Medicinal Products Registration and the Institute for Standardization and Controlintroduced a pilot program designed to accelerate medicinal products registration. This initiative aims to streamline approval processes by leveraging regulatory decisions from leading international health authorities, reducing duplicative review efforts while ensuring public health protection.
Pharmaceutical companies should proactively assess their eligibility for the new expedited medicinal products registration pathways and strategically plan their submissions to maximize regulatory efficiency. By leveraging these reliance-based pathways, companies can significantly reduce approval timelines while ensuring compliance with Ministry of Health requirements. Engaging with experienced legal and regulatory professionals can further streamline the process and mitigate potential challenges.
The pilot program, effective from March 2025, introduces three reliance-based registration pathways:
- First Reliance Pathway (70 business days) – For innovative and biosimilar medicinal products approved within the past three years by at least two regulatory agencies, one of which must be the FDA or EMA.
- Second Reliance Pathway (120 business days) – For innovative and biosimilar medicinal products approved within the last five years by at least one of the following leading health authorities: FDA, MHRA, HC, SMC, TGA, or EMA.
- Generic Medicinal product Pathway (120 business days) – For generics registered within the last three years by at least one of the following leading health authorities: FDA, MHRA, HC, SMC, TGA, or EMA.
Notably, these pathways exclude advanced therapy medicinal products and medicinal products manufactured using novel, unapproved technologies which continue to be approved in the “regular” paths. Additionally, the Ministry of Health has introduced a consultation and guidance pathway for the first-time registration of generic medicinal products in Israel that have not been previously registered in any recognized country, though its launch date is yet to be announced. In each of these pathways, various restrictions apply, and the Ministry of Health reserves the right to deviate from this pilot framework under appropriate circumstances.
Concise Legal Briefing: Essential Updates at a Glance
Upcoming Regulatory Changes in the Pharmaceutical Industry
On February 3, 2025, the newly appointed Director of the Pharmaciuticals Division Mag. Pharm. Miri Trainin, outlined upcoming amendments under the 2023 “Enabling Regulation” framework. Key anticipated changes include:
- Updated Pharmacy Infrastructure Regulations – Allowing the establishment of pharmacies not primarily engaged in direct customer service, with relaxed structural requirements.
- Expansion of Non-Prescription Medicinal Products Sales– Regulations will further clarify the sale of General Sales List (GSL) medications outside of pharmacies.
Stakeholders should closely monitor further regulatory publications to assess the full implications of these changes and evaluate their impact on their specific product portfolios. As these changes progress, companies should conduct a thorough review of their regulatory strategy and adjust their market approach accordingly.
2025 Health Basket Committee Decisions
The Public Committee for Expanding the Health Services Basket has released its 2025 decisions, soon to be formalized in a Director General’s circular. While these decisions align with healthcare priorities, a considerable gap remains between clinical demand and available funding. Consequently, many essential medicinal products were excluded, necessitating alternative market strategies.
Companies should reassess their product portfolios and consider:
- Negotiating access agreements with HMOs.
- Exploring private insurance reimbursement options.
- Leveraging alternative access pathways within the National Health Insurance Law, 1994 framework.
A proactive market strategy can help optimize patient accessibility while ensuring regulatory compliance and financial viability.
Conclusion
These regulatory updates underscore the dynamic landscape of pharmaceutical compliance and healthcare regulations in Israel. Companies should proactively adjust their strategies to ensure compliance, optimize market access, and align with evolving regulatory frameworks. If your organization requires guidance on these developments, we are available to provide strategic support and regulatory insights.
Best regards,
Healthcare & Pharma, Medical Technologies & Life Sciences Practice
