In Israel, pharmaceuticals and medical devices are regulated by various legislative acts and regulatory bodies. The following is a summary of the main legislation and regulatory bodies.

• The main legislations for pharmaceuticals are the Pharmacists Ordinance of 1981 and the Pharmacists Regulations (Preparations) of 1986.
• The Minister of Health and the Ministry of Health (MoH) are the main regulatory bodies. The MoH is the government agency responsible for public health policy and regulation in Israel. It oversees and regulates pharmaceuticals and medical devices, as well as healthcare (providing services through state, mental health and geriatric hospitals), and issues guidelines relating to the various matters for which it is responsible.
• The Pharmacy Department of the MoH oversees the regulation of pharmaceuticals. This includes registration and monitoring of pharmaceutical preparations or medicinal drugs, manufacturing plants, importation/exportation, advertisements, and clinical trials.
• The main pieces of legislation dealing with medical devices are the Medical Device Law of 2012 and the Regulations of 2013. While the Medical Device Law has yet to formally enter into force, the relevant actors are conducting themselves in accordance with it.
• The MoH’s Medical Device Division oversees the regulation of medical devices, including registration and monitoring.
• In addition, Israel’s National Health Insurance Law and those regulations and orders issued in accordance therewith ensure funding for a standardised healthcare package. This package encompasses a range of medical products and services and is regularly updated.
• All Israeli residents are covered by one of four statutorily organised Health Maintenance Organisations (HMOs), based on personal choice, which serve both as insurers and providers of these healthcare services. Some HMOs also manage public hospitals.
• Additional relevant legislation is the Public Health Care Ordinance of 1940, which relates to clinical trials, epidemics, and more.

Decisions made by Israeli regulatory bodies are subject to various legal and administrative challenges.

While there is no process similar to the United States Food and Drug Administration (FDA) citizen petition procedure in Israel, the applicable law provides procedures to challenge decisions (administrative procedures) in certain instances. By way of example, a registered pharmaceutical preparation owner may object to the MoH’s decision not to renew the registration therefor before the MoH’s director (or others in the MoH who were authorised by the director to hear such claims). Another example is individuals seeking funding for treatments not covered by the standard healthcare package (eg, for off-label or compassionate use), who may apply to their HMO’s special committee. Decisions made by these committees can be appealed before the labour courts.

In addition, any Israeli citizen has the right to file an administrative appeal with the administrative courts against the decision of any authority, provided that the decision pertains to matters outlined in the Administrative Matters Courts Law of 2000. In the healthcare sector, decisions subject to challenge may include those entered under the Pharmacists Ordinance, the National Health Insurance Regulations of 2012, the Organ Transplantation Law of 2008, the Public Health Protection (Food) Law of 2015, and any authority’s decision concerning importation under any law, including specific decisions regarding importation licences.

Moreover, governmental decisions can be challenged before the Supreme Court. The Supreme Court also hears appeals and applications for leave to appeal lodged against decisions of the district courts serving as administrative matters courts.

There are two main categories of pharmaceuticals and medical devices in Israel – namely, registered and non-registered. These can be divided into further categories, as described here.

Registered Pharmaceuticals

A “preparation” or “medicinal drug” should be registered in the Israeli Drug Registry according to the MoH’s requirements (see 3.1 Product Classification: Pharmaceuticals or Medical Devices). Registered preparations can be further categorized as follows.

• Prescription Only (Rx) – prescription-only preparations may be provided only to consumers with a prescription at pharmacies and by certified pharmacists.
• OTC Medicines – P (Pharmacist) ‒ a preparation whose provision does not require a prescription yet is provided only in pharmacies by certified pharmacists.
• OTC – General Sale List (GSL) – non-prescription preparations that may be provided to consumers not by pharmacists and outside pharmacies, according to the Pharmacists Regulations (sale of a preparation without a prescription not in a pharmacy or not by a pharmacist) of 2004 and the MoH guidelines of 2011. The regulation includes a list of the Active Pharmaceutical Ingredients (APIs) that may be included in GSL preparations.

Non-registered Pharmaceuticals

The general rule is that it is not possible to provide consumers with a preparation unless it is registered. This is the case also for off-label uses of registered preparations, as was determined by the Israeli Supreme Court in the Tibet case of 1984.

However, the MoH may allow specific preparations to be imported, manufactured, or marketed without registration or in an off-label manner for uses such as research or essential treatments or for export purposes, provided the MoH determines it will not negatively impact public health. Such allowances may also be made in cases of non-commercial quantities for personal use, preparations made in Israel or imported for registration purposes, preparations intended for treating epidemics, and registered preparations for off-label use by medical institutions for their patients. The MoH’s guidelines provide more details on such cases (see also 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations).

Registered Medical Devices

Medical devices should be registered in the Medical Device Registry of the MoH’s Medical Device Division (AMAR).

Non-registered Medical Devices

The Medical Devices Law allows the Minister of Health to issue regulations that exclude certain types of medical devices from the registration requirement for purposes such as R&D, export, emergency, and more. A draft of such regulations was published in August 2023 for public comments but has not yet been enacted.

The Public Health Ordinance of 1940 and the Public Health Regulations (Medical Experiments on Humans) of 1980, which apply the Declaration of Helsinki, are the main legal acts overseeing clinical trials in Israel. In addition, several MoH guidelines and circulars apply. For actors interested in conducting trials in Israel, the main guideline is Guideline 14 on Medical Experiments on Humans (2020), which governs the submission and approval of clinical trials.

The guidelines include the requirement that the principal investigator adhere to international Good Clinical Practice (GCP) guidelines and ISO 14155 (Clinical Investigation of Medical Devices for Human Subjects).

In addition, legislation relevant to the realm of the specific research may apply, such as the Physicians Ordinance, the Patients’ Rights Law, the Genetic Information Law, privacy laws, the Medical Equipment Law and standards, the Prohibition of Genetic Intervention Law (Human Cloning and Genetic Modification of Reproductive Cells), and the Dangerous Drugs Ordinance.

The procedure for securing authorisation to conduct clinical trials in Israel is outlined in the Public Health Regulations and the MoH’s Guideline 14, as described in 2.1 Regulation of Clinical Trials.

The approval process entails a dual scrutiny mechanism involving assessment by both the medical institution’s Helsinki Committee and the MoH. In many kinds of “specialised medical trials”, as defined in the regulations (eg, trials on registered preparations and medical devices), approval by the institution’s director is sufficient.

Trials relating to human genetics, non-natural female fertilisation, and others determined by the MoH require the opinion of the Higher Helsinki Committee. This committee may also approve urgent medical cases where the informed consent of a trial participant cannot be given.

Trials on existing data or questionnaires also require approvals and have specific instructions in the guidelines.

Multi-centre trials are evaluated by a dedicated national committee, according to the MoH’s Guideline 168 of 2023.

According to the MoH’s Guideline 14, the initiation of a clinical trial is contingent upon its registration within the MoH website MyTrial. The information presented on the MyTrial website includes details on the disease/medical condition, the intervention being tested, how the trial is conducted, criteria for inclusion and exclusion, a list of the centres where the trial is conducted, and contact details for obtaining further information.

Exemptions to registration on the MyTrial website can be requested from the Helsinki Committee. They can be based on reasons of IP in feasibility trials, as long as the trial was not registered on the USA’s National Institutes of Health (NIH) website.

The use of digital means in the process of obtaining informed consent is regulated under the MoH’s Guideline 169/01. The guideline refers to the use of digital means in presenting the information to the participants and verifying their understanding, as well as the use of such means in obtaining informed consent and documenting the process. The use of such digital means requires the approval of the Helsinki Committee as part of the approval of the trial.

In addition, restrictions under additional laws and regulations exist, such as those outlined in 2.5 Use of Data Resulting From Clinical Trials.

The informed consent forms provided in the MoH’s Guideline 14 state that the consent to participate in the trial also includes consent for medical and personal information collected during the trial to be transferred to an external party for data processing. The information is to be transferred in an encoded form, free of identifying details, with the link between the code and the identifying details being kept securely by the Principal Investigator in Israel. Changes in these forms require the approval of the Helsinki Committee.

In addition, to the extent that the resulting data from the trials amount to a database containing identifying information about an individual (eg, their health status), it should be considered a database of “sensitive data” according to the Protection of Privacy Law of 1981. The use of such a database is subject to the provisions outlined in the law and regulations ‒ examples of which include the following.

• If an external service provider needs access to the database in order to provide a service, the agreement with such service provider must include provisions set forth in the Protection of Privacy Regulations (Data Security) of 2017 (such as provisions referring to the data security implementation, confidentiality, and annual reports).
• Transfer of data from such a database to a third party outside Israel is governed by the Protection of Privacy Regulations (Transfer of Data to Databases Outside the State Borders) of 2001. These regulations set out conditions for transferring data abroad ‒ for example, the transferee must undertake to comply with the conditions for data retention and use applying to a database located in Israel or the transferee must be a corporation under the control of the database owner that has assured the protection of privacy after the transfer.

Two MoH circulars from 2018 relate to secondary uses of health data and collaborations based on such data. The circulars include various measures to protect the data, such as de-identification, requirements for approvals, and security measures.

If the data in the database is identifying, then the database should be subject to the provisions of the Protection of Privacy Law and its regulations, including those described in 2.5 Use of Data Resulting From Clinical Trials. This may require registration of the database if sensitive information such as health conditions are included, more than 10,000 persons are included in the database, or for other reasons defined in the law. Such inclusion may also require the implementation of adequate security measures stipulated in the Protection of Privacy Regulations (Data Security) of 2017. Amendment No 14 of the Privacy Protection Law – currently under legislative procedure ‒ seeks to revise the definition of “sensitive data” to encompass, inter alia, medical data as defined in the Patients’ Rights Law of 1996 and genetic data as defined in the Genetics Information Law of 2000.

According to the Israeli Pharmacists Ordinance, “preparation” or “medicinal drug” is any form of substance that has properties for curing or preventing a disease or for the treatment of a disease ‒ or that is presented as having such features that cause (or is given for the purpose of causing, restoring, replacing, repairing or changing) a physiological action in the body through pharmacological, immunological, or metabolic action ‒ and is given (or can be given) for medical diagnosis.

The Medical Device Law excludes preparations (see 1.3 Different Categories of Pharmaceuticals and Medical Devices) from the definition of “medical device” but includes any of the following:

• a device used for medical treatment, as well as a device or computer software required for operating such a device ‒ for this purpose, “device” includes an accessory, chemical substance, biological product, or biotechnological product;
• contact lenses; and
• an electrical device that emits ionising or non-ionising radiation used for cosmetic treatment.

Additionally, in 2002 (a decade before the Medical Device Law was enacted), the MoH issued a guideline classifying medical products that combine preparations and medical devices or whose classification is unclear/disputed (Guideline 47). The guideline includes rules on how to classify the product, as well as the classifications of specific products (such as bandages containing medical material, biological glue, ultrasound gels, condoms, and more).

Requests for early designation may be filed with the medical assistant of the Preparations Registration Department or the Medical Device Division in the MoH. Appeals are made to the Deputy General Director of the MoH.

In general, registration of original biologic medicinal products (which makes it possible to market those products – see 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices) requires that a quality certificate be obtained from the MoH for that product.

Where a biosimilar – namely, a pharmaceutical comprising a biological active ingredient that is similar to the active ingredient of an already registered original biological pharmaceutical – is concerned, the MoH’s guideline PRA-127/03 is applied. The guideline adopts the European Medicines Agency’s policy regarding registration ‒ with changes ‒ and registration is usually dependent on showing actual registration for the biosimilar (or a positive opinion regarding it) from one of several foreign countries, as well as on the provision of data proving that there is no significant difference in aspects of quality, safety and efficacy between the biosimilar and the original biological medicinal product.

The basic requirement for marketing pharmaceuticals and medical devices is their registration. The initial period of validity for such registration is typically no more than five years and is subject to renewals. In certain circumstances, the MoH may prohibit the marketing of a preparation or medical device, revoke its registration, and take any action required to ensure public health.

Pharmaceuticals

In general, retail marketing of preparations can only be done by pharmacists in pharmacies. Wholesale marketing of preparations can be carried out only by “pharmaceutical trading houses”, which store, distribute, and transport preparations or raw materials.

According to the Pharmacists Regulations (Preparations), the first registration of a preparation shall not exceed five years. A renewal may be limited or unlimited in time, depending on quality, efficiency, or safety reasons.

A registered preparation marketed for the first time must receive marketing authorisation from the MoH for the first batch. Marketing of any further batches requires the authorisation of a responsible pharmacist in a business that has received authorisation from the MoH to act as such.

A preparation whose registration has not been renewed, or has been cancelled, may continue to be marketed for a period not exceeding one year from the expiration of the registration.

Medical Devices

The general rule for the first registration of a medical device is the same as for preparations ‒ ie, it shall not exceed five years. This is according to the Medical Devices Regulations (Registration of Medical Equipment in the Register and its Renewal) of 2013. The registration may be renewed.

According to the Medical Devices Law, a medical device whose registration has not been renewed or has been deleted or cancelled may continue to be marketed for a period not exceeding two years from the expiration of the registration.

Pharmaceuticals

The basic requirement for marketing pharmaceuticals and medical devices is their registration, as noted in 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices.

To register a preparation, apart from adhering to the Pharmacists Law and Regulation, applicants must submit an application to the Preparations Registration Department of the MoH. This application is exclusively available to Israeli residents or registered Israeli corporations and should be filed by a pharmacist approved by the MoH for such a purpose.

The procedure adheres to MoH Circular No 08_2012 – “Application Submission Guideline for the Registration of Medical Preparations (Including Changes and Renewals)” (last updated in 2015). The circular classifies pharmaceutical preparations into six groups, including new APIs, generics, and biosimilars ‒ each with specific requirements.

Any change in a registered preparation should be brought to the attention of the MoH, and the circular includes procedures for changing the registration (such as changes in indication, dosage, and manufacturing plant). Another circular, No EX-009/04, relates to changes from a quality perspective and is based on the EC guidelines (mainly EC 1234/2008).

MoH Guideline No 36 delineates the procedure for changing the registration holder. This process necessitates the manufacturer’s declaration regarding the new registration holder, including their unrestricted access to all confidential information contained within the product file.

Medical Devices

To register a medical device, applicants must complete an application, which is to be submitted to the Medical Device Division of the MoH according to the relevant guidelines. This application must include valid regulatory approvals, encompassing safety and efficiency certifications issued by recognised certifying bodies abroad (such as FDA, Conformité Européenne (CE), and International Organization for Standardization (ISO) approvals) or documentation corresponding to the device’s class.

In 2024, the MoH published a guideline allowing registration of low-risk devices (Class I) using a declaration of the registration owner/importer only. This is part of a reform in the registration procedure for medical devices that was published in August 2023 and is aimed to shorten the registration times of medical devices in Classes 1 and 2.

Transfer of registration to another holder shall be submitted along with, inter alia, a letter of consent from the current registration holder, declarations from the manufacturer and the importer, and other requirements detailed in the MoH’s guideline.

Preparations and medical devices that are not registered may be supplied in specific circumstances, as detailed here.

Pharmaceuticals

The Pharmacists Regulations (Preparations) delineate certain exceptions to the regular requirements for preparations (such as registration and batch approvals), subject to MoH approval/requirements. These exceptions include materials used without any process or change, preparations in non-commercial and small quantities, personal use of such, use for research, local manufacture for export purposes, use for epidemic purposes, and registered preparation for off-label use.

The MoH published several guidelines concerning the exceptions, which include various requirements, forms and approvals.

Medical Devices

The Medical Device Act grants authority to the Minister of Health to establish regulations governing exceptions to the registration requirement under specific circumstances outlined in the Act.

Such regulations have not yet been enacted. However, in August 2023, the MoH released draft regulations, which proposed allowing the use of unregistered medical devices in the following cases:

essential medical treatment and urgent care in the absence of a registered, marketed, and available alternative;

compassionate treatments;

research, development, and production of medical equipment not intended for marketing purposes;

emergency preparedness;

export-only purposes;

conducting clinical evaluations in a limited number of patients; and

personal use of customised medical equipment by a therapist.

Pharmacovigilence is defined here as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects – in particular, the long-term and short-term side effects of medicines.

Technovigilance is defined here as the science relating to the detection, assessment, understanding and prevention of adverse incidents – in particular, the long-term and short-term side effects of medical devices.       

Pharmaceuticals

The preparation registration owner must maintain a drug monitoring system, for which a physician/pharmacist with at least two years’ experience will be responsible.

The preparation registration owner must notify the MoH of any change in the registration file. MoH Guideline No 6 – “Reporting Adverse Events and New Safety Information” details which information should be provided and additional relevant requirements. Among other things, the MoH guidelines require creating a system for monitoring side effects and new safety information for the registered preparation (pharmacovigilance system), providing Periodic Benefit-Risk Evaluation Reports (PBRER) or Periodic Safety Update Reports (PSUR), post-marketing spontaneous reporting of individual case safety reports, and follow-up on serious side effects.

The MoH may impose additional conditions on registration or renewal of the preparation, such as requiring regular and ongoing supply of the preparation.

Medical Devices

Section 7 of the Medical Device Law outlines the parameters that the MoH may impose during the registration phase of medical devices. These include requirements for transportation and storage, the regular supply of the medical device in question, and others. Renewals may also require the filing of information regarding ongoing obligations.

The Medical Device Law also authorises the Minister of Health to establish quality control regulations. However, these regulations have not yet been issued.

Pending applications for marketing authorisations for pharmaceuticals and medical devices remain confidential until registration. Basic information only (such as name, active ingredients, indications, dosage forms, and other details) becomes accessible to third parties upon completion of the registration process. The Israeli Drug Registry is available on the MoH’s website, which also features additional information such as information on preparations that are no longer marketed in Israel and notices regarding certain side effects and defects.

The MOH may use data to authorise generics only after the market exclusivity period ends, as detailed in section 10.4 below.

Medical Devices

Registered Israeli Medical Devices are public and available on the MoH’s website. At this stage, the information available online is not complete.

Medicines

The Pharmacists Ordinance aims to prevent danger to public health from, inter alia, falsified and illegally distributed medicine.

The Ordinance defines several offences, including:

• marketing a preparation that is not a registered preparation and not in accordance with the registration and the Ordinance; and
• marketing a preparation not in a pharmacy, a pharmaceutical trading house, or another recognised institution.

Furthermore, the Ordinance authorises the MOH to supervise and enforce the rules and to impose fines.

In addition, Chapter 8 of the Ordinance constitutes disciplinary offences for pharmacists, and a disciplinary committee is authorised to examine such offences.

The Dangerous Drugs Ordinance (New Version), 5733-1973 (the “Dangerous Drugs Ordinance”) governs and restricts dealing with hazardous drugs. It defines which substances are dangerous drugs and bans the importation, exportation, manufacture, preparation, procurement, possession, and use of dangerous drugs. It empowers the MOH to permit and issue licences for conducting banned acts – for example, when dealing with cannabis for medical needs and research.

In addition, the production and distribution of falsified or illegal medicines may amount to criminal offences under the Penal Law of 1977, such as in cases where the counterfeit medicine is accompanied by a counterfeit leaflet and the use of forged documents.

Medical Devices

Breaches of the Medical Devices Act, such as manufacturing or marketing of an unregistered medical device, may amount to a criminal offence and result in fines (double fines for corporations) and up to three years of imprisonment. The Medical Devices Act also authorises the Minister of Health to appoint inspectors to supervise the implementation of the law.

There are also civil torts (other than those based on IP rights) that may be a tool in the fight against the distribution of illegal medicines and medical devices:

• consumer deception under the Consumer Protection Law of 1981;
• unjust enrichment under the Unjust Enrichment Law of 1979; and
• misappropriation of goodwill.

In accordance with the customs IP procedure, as set out in Section 200A of the Customs Ordinance, the customs authorities may detain shipments containing goods, including pharmaceuticals and medical devices suspected of being counterfeit and infringing IP rights (of trade marks, copyrights, and designs). The detainment may occur either pursuant to a complaint filed by the rights owner or at the customs authorities’ initiative.

There are two procedures that may be implemented by the customs authorities: the regular procedure (RP) and the expedited procedure (EP). Following the detainment, the customs authorities notify the rights owner (via the local firm indicated as the address for customs matters) about the detainment and the procedure implemented regarding the shipment.

Customs’ Regular Procedure

The RP is usually applied in shipments containing large quantities of goods. Within the timeframe of three business days, the rights owner has to inform customs whether the goods are counterfeit (a three-business-day extension may be requested). In the case of counterfeit goods, the rights owner has to file a bank guarantee, according to the sum specified in customs’ notice of detainment. Only then do the customs authorities disclose the identity of the importer.

According to the RP, the rights owner should subsequently file a civil action against the importer within ten business days from the day of the detainment notice (extension available). The goods will be detained until the end of such court proceedings.

Customs’ Expedited Procedure

Customs more commonly implements the EP. It is a more cost-efficient procedure than the RP and, as its name implies, is a shorter process.

Within the timeframe of three business days from the notice of detainment, the rights owner should provide customs with:

• an opinion indicating whether the goods are infringing, including brief details of their counterfeit nature; and
• an undertaking for indemnification to cover possible unjustified damages that may be caused to the importer as a result of the goods’ detention (such damage, if any, will be determined by the court) and to join legal proceedings regarding the release of the goods should the importer of the shipment initiate such proceedings against customs.

If needed, the rights owner may request an extension.

After these documents are provided to customs, the detained goods are destroyed without revealing the importer’s identity to the rights owner. However, when the EP is implemented, customs may grant the rights owner the option of implementing the regular procedure alternatively.

Manufacturing of Pharmaceuticals

The manufacturing of pharmaceuticals is regulated by the Pharmacists Ordinance and the Preparations Regulations mentioned in previous sections, as well as by specific regulations relating to production conditions for preparation  and by the guidelines of the MoH. Among other things:

• the plant should be operated by skilled professionals, including a QA manager, a lead pharmacist, and a business manager;
• the preparations should be manufactured according to Good Manufacturing Practices (GMP) and the principles of EU Directives 2003/94/EC for human preparations;
• the APIs used in manufacturing the preparation should be manufactured according to GMP and the principles of EU Directive EC/2001/83;
• the MoH must audit the business according to the EMA’s “Compilation of Community Procedures on Inspections and Exchange of Information”; and
• the plant must have a business licence pursuant to the Business Licensing Law.

Manufacturing of Medical Devices

The manufacturing of medical devices is regulated by the Medical Devices Law, regulations, and guidelines of the MoH.

The manufacturing plant’s GMP should meet the requirements of ISO 13485, as well as have a business licence pursuant to the Business Licensing Law.

Transportation conditions must meet the requirements of ISO9001, as well as a business licence for storage and transportation of medical devices pursuant to the Business Licensing Law.

Pharmaceuticals

Wholesale marketing of preparations can be done only by “pharmaceutical trading houses” that store, distribute, and transport preparations or raw materials (as noted in 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices and 3.8 Rules Against Illegal Medicines and/or Medical Devices). The pharmaceutical trading houses should be managed by a pharmacist approved by the MoH according to Guideline 139.

Wholesale is also allowed by institutions that were acknowledged by the Minister of Health. The Minister of Health is also authorised to allow wholesale in other cases for necessary treatment, research or registration, provided such actions do not pose any detriment to public health.

Distribution and storage should be according to Guidelines 126 and 130 of the MoH.

Non-prescription medicines may be sold subject to approval by the district pharmacist according to the Pharmacist Regulations (sale of medicine without a prescription not in a pharmacy or not by a pharmacist) of 2004 and under Guideline 56 of the MoH.

Medical Devices

The sale of medical devices necessitates registering the equipment in the registry, while exceptions may exist (see 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices and 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations).

In Israel, there are two main categories of  pharmaceuticals. The first is registered pharmaceuticals and the second is non-registered pharmaceuticals. For a detailed explanation, please see 1.3 Different Categories of Pharmaceuticals and Medical Devices.

The importation and exportation of products are mainly governed by the Import and Export Ordinance of 1979, the Customs Ordinance, and the Free Import Order of 2014. In addition, specific regulations and MoH guidelines exist for the importation and exportation of pharmaceuticals and medical devices, which necessitate approvals from the Import of Pharmaceuticals and Drugs Department or the Medical Equipment Division within the MoH. Guideline 33 governs the submission and handling of applications for import approval. Guideline EX-015/02 outlines the procedures for granting, renewing, updating, suspending, and revoking approvals for importers of pharmaceuticals.

At the point of entry, the customs authorities are responsible for enforcing import regulations. Following entry into the country, ongoing enforcement and oversight are maintained by various entities within the MoH, such as the Pharmaceutical Administration and the Medical Device Division.

There is no official definition of “Importer of Record” in Israel.

Importers of pharmaceuticals and medical devices are generally required to obtain prior authorisations from the MoH, as mentioned in 6.1 Governing Law for the Importation and Exportation of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies. The Ordinance defines “marketing” as including importation and therefore any approval required for marketing is also applicable for importation (see 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices and 5.1 Wholesale of Pharmaceuticals and Medical Devices).

Exemptions exist, according to Regulation 29 (see 1.3 Different Categories of Pharmaceuticals and Medical Devices). In addition, in view of the “Iron Swords” war, the MoH published a donation outline for medical devices, allowing the importation of specific medical devices without MoH import authorisation under certain conditions. 

The Pharmacists Ordinance permits the parallel import of a product equivalent to a registered preparation by entities other than the registration holder, provided it matches the registered item in identity and meets regulatory storage and delivery conditions. Except for the requirement of registration itself, all rules applicable to the registered preparation also apply to the imported equivalent on a comparable basis.

From an IP perspective, importing a product protected by a local patent for purposes such as production, use, sale, or offering for sale is regarded as exploitation of the invention. Therefore, if a pharmaceutical or medical device has a related registered patent/s in Israel, the importer is obligated to obtain consent from the patentee prior to importing the product.

The Import and Export Ordinance of 1979, the Customs Ordinance, and the Free Import Order of 2014 include various non-tariff regulations and restrictions imposed upon importation.

Israel has signed many free trade agreements and trade pacts with multiple countries and economic blocs, including the USA, EU (including an Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA)), European Free Trade Association (EFTA), the UK, South Korea, China, Eurasian Economic Union, India, Mercosur (a South American trade bloc comprising Argentina, Brazil, Paraguay and Uruguay), and neighbouring/regional countries such as Jordan, Egypt, Turkey, and the UAE.

Although the prices of medical devices are not controlled, the prices of pharmaceuticals are. Specifically, the Supervision of Prices of Commodities and Services (Maximum Prices for Prescription Preparations) Order of 2001 determines maximum prices for prescription preparations, as elaborated on in 7.2 Price Levels of Pharmaceuticals or Medical Devices.

As for preparations sold without prescriptions, the Supervision of Prices of Commodities and Services (Application of the Law on Preparations) Order of 2001 provides that the prices of such preparations may not be raised without their sellers first obtaining governmental approval.

When it comes to GSL preparations, the same order provides that the registrants of such are to provide a biannual report to the MoH in which they are to detail the prices of all preparations they are selling, as well as provide an annual report regarding their profitability from the sales thereof.

The prices of medical devices are not controlled. As regards pharmaceuticals, the Supervision Order of 2001 noted in 7.1 Price Control for Pharmaceuticals and Medical Devices provides that the maximum price of prescription preparations is to be determined as an average of the lowest three prices for that preparation in the following European countries: Belgium, the Netherlands, Hungary, Spain, France, the UK, and Germany.

The order further provides that where that prescription preparation is not sold in three of the above-mentioned seven countries, the price of a given preparation would be set as the average of the prices therefor in the two countries in which it is being sold. Finally, where the preparation is sold in only one of the seven countries referenced by the order, that price alone would be used to set the maximum price for that preparation in Israel.

As mentioned in 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices, Israel nationalised its healthcare system in 1994 when it enacted the National Health Law. This law provides a lengthy list of all the healthcare services to which all residents of Israel are entitled, which is formally known as the “Health Service Basket” or ‒ more commonly ‒ the “Health Basket”.

Once a given pharmaceutical or a medical device has been introduced into the Health Basket, they are subsidised by the State and provided by HMOs. In particular cases, patients may request reimbursement for pharmaceuticals or medical devices that are not included in the Health Basket. Such requests are evaluated on a case-by-case basis by healthcare providers, who consider factors such as medical necessity, lack of alternative treatments, and clinical justification.

The Health Basket is updated on a yearly basis, according to the recommendations of a public committee, which are then assessed by the government before a decision is made. Given that the annual budget for this purpose is always limited, a cost-benefit analysis is always carried out. Specifically, the public must consider the benefits offered by a given preparation or device against the costs thereof ‒ both at the individual and the national level – and rank these prospective additions accordingly. In certain cases, negotiations are carried out between the State of Israel and the companies to secure hedges, which would place a cap on the total cost incurred as a result of a company’s product being included in the Health Basket.

A cost-benefit analysis is also carried out in a way whereby the maximum prices for prescription preparations are concerned: as noted in 7.1 Price Control for Pharmaceuticals and Medical Devices, it is permissible to set a higher price than that which would have otherwise been set if setting a lower price might cause the preparation not to be marketed in Israel.

The Physicians’ Regulations (Provision of Prescription) 1981 lists the details to be included in a prescription, as well as allows such to be issued digitally. When it comes to dispensing prescriptions, the Pharmacists’ Ordinance provides that unless the physician clearly states that the preparation is not switched, the pharmacist may provide a generic product thereof and would have to advise the patient which additional generics for that preparation are available at the dispensing pharmacy.

In practice, HMOs instruct their physicians – when possible – to not include such clear statements in their prescriptions so as to have pharmacists dispense generic preparations rather than ethical preparations, thus curbing spending.

There are no specific rules for medical apps in Israel. However, the definition of a Medical Device (see 3.1 Product Classification: Pharmaceuticals or Medical Devices) may include a medical app in cases where it is required for operating a medical device. Such an app may therefore be subject, in principle, to the Medical Device Law.

While there are no specific and separate laws tailored exclusively for telemedicine, the MoH issued several circulars pertaining specifically to telemedicine and digital health data – in particular, the circular on criteria for operating a remote health service (Telemedicine) of 2019, which allows HMOs’ management to approve specific telemedicine services without obtaining the MoH’s approval. Additional relevant circulars are the 2019 circular regarding patient access to personal health data and the 2018 circulars on secondary uses of health data (see 2.5 Use of Data Resulting From Clinical Trials).

In accordance with the above-mentioned circulars, physicians in Israel may provide telemedicine services, subject to their ensuring that telemedicine consultations are conducted in a manner that ensures patient safety, confidentiality and privacy.

The Israeli Privacy Protection Authority released documents in this regard, relating to privacy protection within the realm of telemedicine services, identifying the various types of remote medical services currently offered in Israel, assessing the risks to patients’ privacy, outlining pertinent legal provisions and guidelines, and specifying recommendations for the use of health and fitness applications.

In general, the promotion and/or advertising of medicines and medical devices (through any means of communication) is regulated under the Pharmacists Regulations and Medical Equipment Law as well as under the MoH’s guidelines, including the following:

• Guideline 24, relating to the advertisement of preparations;
• Guideline 137, relating to “Rules for improved educated use and compliance to medical treatment of prescribed medicine, through non-commercial information”; and
• Guideline 134, relating to “Raising diseases awareness ‒ rules for accessibility of information to the public, funded by the registration owner directly or by third parties”.

Online advertising of preparations requires approval in advance from the MoH in most cases (unless it is in a professional/scientific journal).

In addition, an MoH circular also governs the advertisement of medicinal products to healthcare professionals, setting rules for health institutions’ commercial engagements. The Rules of the Israeli Broadcast Authority (Commercials and Radio Notices) of 1993, as well as the Rules of the Second Authority for TV and Radio (Ethics in TV and Radio) of 1994 and 1999, are relevant as well.

As regards medical devices, the MoH has the power to establish – within the framework of a medical device registration ‒ terms and limitations concerning the method and content of medical device advertising.

The requirements that apply to traditional forms of advertising also apply to online promotion through websites, social media platforms, and other digital channels.

Electronic prescriptions are regulated and allowed in Israel, according to Physicians’ Regulations (provision of a prescription) of 1981, subject to the integrity of the physician’s electronic signature being maintained. The MoH has implemented regulations and guidelines to facilitate the use of electronic prescriptions as part of efforts to enhance efficiency, accuracy, and safety in medication management and dispensing processes. 

Procedure 128 of the Pharmacy Division, entitled “Transportation services and delivery of preparations from a pharmacy through online sales or couriers”, regulates the accessibility of remote pharmacy services ‒ namely, the ordering of medicines and medical devices online and delivering them to patients.

Recently, in December 2023, the MoH published a draft update to Procedure 128 as part of a regulatory reform. The update includes various guidelines aimed at easing online sales of medicines.

The Patients’ Rights Law of 1996 defines a “medical record” as medical information documented in any way and thus regulates electronic health records as well. Medical data is considered sensitive data (see in 2.5 Use of Data Resulting From Clinical Trials and 2.6 Databases Containing Personal or Sensitive Data for further details).

There are no special requirements for cloud platforms. Medical data can be transferred and stored on cloud platforms, subject to the platform complying with the privacy legal requirements (see examples in 2.5 Use of Data Resulting From Clinical Trials).

In Israel, patents are governed primarily by the Patents Law of 1967, which regulates the grant, enforcement, and protection of patents. Also important are the Patent Regulations (Authority Practice, Rules of Procedure, Documents, and Fees) of 1968, the Israeli Patent Registrar circulars, and the Examination Guidelines of the Israeli Patent Office.

The Patents Law includes stipulations on extending the term of pharmaceutical and medical device patents, as elaborated in 9.3 Patent Term Extension for Pharmaceuticals.

While there are no patentability requirements in the Patents Law that are specific to pharmaceuticals or medical devices, the Examination Guidelines and circulars include specific guidelines on life science-related inventions, such as polymorphs and salts, antibodies, biotech, functional definition (mechanism of action), personalised medicine (including treatment of the target populations) and computer-related medical inventions.

Israel has a patent pre-grant opposition system, whereby third parties may oppose the grant of a patent within three months from the publication of its allowance. The Israeli pharmaceuticals industry uses this procedure often, as filing such opposition delays the grant of a patent and the burden of proof lies on the applicant.

Common issues encountered by pharmaceuticals and medical device products under Israeli patent legislation include questions of the novelty and inventive step embodied in inventions such as salt forms, polymorphs, dosage regimes, and second medical uses, which are often challenged by opponents and revocation-seeking parties alike. As regards subject matter eligibility, Israeli law includes an exclusion from patentability of procedures for therapeutic treatment on the human body.

Second and subsequent medical uses of a known product or process may be patentable and are judged under the same patentability requirements governing other inventions ‒ mainly, whether the second use in question is novel, embodies an inventive step, and is useful.

According to the Examination Guidelines, a claim relating to a medical use may concern the prevention, diagnosis, treatment, or improvement of a medical condition (such as a disease, syndrome, and/or functional disorder), symptoms related to any medical condition or the side effects of any treatment.

Where dosage regimens are concerned, for example, they are not excluded from patentability. The questions to be asked are whether the new regimen is novel and whether it embodies an inventive step over the prior state of the art and, specifically, the dosage regimens mentioned therein.

Infringement of second and subsequent patents of pharmaceutical products may crystallise by a non-owner exploiting the invention claimed therein, with such exploitation being either the production, use, offer for sale, sale of the invention (or the essence thereof), or the importing of it for purposes of one of the said acts.

Under Israeli law, a patent’s term may be extended by up to five years via a Patent Term Extension Order (“PTE order”).

Under the Israeli PTE scheme, a patent claiming any of the following may be considered a “basic patent” that is eligible for a term extension, subject to the following statutory conditions being satisfied:

• APIs;
• use(s) of APIs;
• finished drugs;
• manufacturing process(es) of APIs;
• finished drugs’ manufacturing processes; or
• medical devices.

Once an owner of a basic patent (or an applicant whose application may mature into one) files a PTE application, the Patent Office will examine whether the following conditions have been met:

• the PTE application was filed in good faith.
• the basic patent is in force.
• the pharmaceutical preparation of the drug containing the API is registered in the Israeli Preparations Register and is the first one made.
• there are no other PTE applications for the same API or for the same basic patent; and
• marketing authorisation was issued in the USA and/or in any of five EU countries (the UK, France, Germany, Italy, and Spain) and a US PTE and/or EU SPC (respectively) was granted before the expiry of the basic patent (the “Reference Countries” and the “Reference Patents”).

If all of these conditions are found to have been satisfied and if the applicant is found to have acted in accordance with the timeframes and procedures set out in the Patents Law and applying regulations, the term of the patent would be extended.

The duration of an Israeli PTE order shall equal the shortest term of extension granted to either of the Reference Patents and, in any case, would not exceed five years or 14 years from the issuance of the first marketing authorisation in any of the Reference Countries. In addition, a PTE order would expire upon the revocation of the PTE/SPC orders (or underlying Reference Patents) on the basis of which it was granted.

Any person may oppose the issuance of a PTE order before such is granted, as well as after, on the basis that the above-listed conditions were not met or that the procedural requirements were not adhered to.

Patent infringement may be established by an unauthorised party exploiting the invention as defined in the claims (literal infringement) or by exploiting the “essence of the invention in light of the claims” (non-literal infringements, which may be compared to the doctrine of equivalents). This general rule does not change where pharmaceutical or medical device patent infringement is concerned.

Application for marketing authorisation or a threat of infringement are not actionable in themselves, as they do not fall within the definition of exploitation. However, ex parte interlocutory remedies may be sought immediately once an infringer has crossed the line.

In general, the unauthorised exploitation of a patented invention would not be considered infringing if that exploitation is either non-commercial, an experimental act aimed at improving the invention or developing another invention, or an experimental act towards obtaining regulatory licences after the lapse of the patent (a Bolar-type exception).

Any grounds on which the grant of a patent may be opposed will be a good defence in an action for infringement. Namely, defendants are entitled to challenge the patent’s validity. Additional defences may be prior use of the invention by the defendant, exhaustion of rights, and a licence having been granted.

Although the Patents Law empowers the Patents Registrar to issue compulsory licences subject to the satisfaction of statutory criteria, such a licence would only allow the exploitation of a given invention after it is issued and not retrospectively, meaning that seeking such would not be helpful once an infringement has been made.

Israeli law recognises two types of compulsory licences. The first type is issued where a patent owner has been shown to have abused their monopoly power and the second is issued where a later inventor has shown that their patented invention incorporates an important technological innovation over the earlier invention, is of great economic importance, and cannot be exploited without the patent in question being exploited as well. Once a compulsory licence has been granted, compensation to the owner of the compulsory licensed patent would be set as well.

An infringement action must involve, on the plaintiff’s side, the patent owner or their exclusive licensee. Where a patent is co-owned, each co-owner may file an infringement claim. If the other co-owners (or the exclusive licensee) do not join as plaintiffs, the suing co-owner must name them as defendants. This is also true where a patent owner does not join an exclusive licensee’s claim and vice versa.

Patent infringement actions are initiated through the filing of a statement of claim to the relevant district court ‒ following which, the defendant files a statement of defence, with the plaintiff allowed to file a short statement in response thereto. Discovery proceedings follow ‒ after which, the parties submit evidence, cross-examinations are held, summary briefs are submitted, and a judgment is issued.

Defendants challenging the patent’s validity are required to make that challenge in their statement of defence and displace the burden of proof with regard thereto during the evidentiary stage.

A prevailing party will be entitled to an injunction preventing prospective infringement as well as to damages. In awarding compensation, the court shall take into consideration:

• the direct damages caused to the plaintiff;
• the extent of the infringement;
• the profits derived by the infringer from the act of infringement; and
• the reasonable royalties that the infringer would have had to pay in consideration for a licence.

The plaintiff may opt between damages due to loss of profit and the profit made by the defendant amounting to unjust enrichment. Adjudication of reasonable royalties may be warranted where the plaintiff’s business model is to issue licences at arm’s length.

The Patents Law further empowers the court to order the infringer to provide accounts on the basis of which calculation of damage may be effected. If such an order is made, it is possible that a supplementary judgment would be issued, in which only the issue of the damages is addressed. Otherwise, the claim for damages would be heard as part of the main claim.

In addition, if an infringement was committed after the patentee or its exclusive licensee warned the infringer, the court may order double damages.

A potential generic entrant looking to “clear the way” could launch a pre-grant opposition procedure against the patent application, ostensibly blocking its path, or file revocation proceedings in the Israeli Patent Office in case the patent has already been granted (which may delay any infringement lawsuit) or seek a declaratory non-infringement order from the court.

However, the generic entrant does not have to take any of these actions and may simply launch a product “at risk” – namely, when there is a patent claiming it. There is no patent linkage in Israel and the authorisation of a given pharmaceutical or medical device does not depend on the status of any patent.

Counterfeiting pharmaceuticals and medical devices may amount to both criminal offences as well as civil torts – as elaborated in 3.8 Rules Against Illegal Medicines and/or Medical Devices.

The Patents Law, the Trade Marks Ordinance of 1972, the Merchandise Marks Ordinance of 1929, the Copyright Law of 2007 and the Design Law of 2017 all set out cases in which patent, trade mark, copyright and design infringement ‒ typically carried out in the framework of the counterfeiting activity – may amount to a criminal act (in addition to being civil torts).

These laws are joined by sections in both the Pharmacists Ordinance and the Medical Devices Law (which is not yet in force, as mentioned in 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices), which include dedicated chapters dealing with counterfeiting and the acts associated therewith (such as selling defective products), brand them as criminal offences, and detail the sanctions therefor (see 3.8 Rules Against Illegal Medicines and/or Medical Devices).

Where a criminal offence has been carried out, Israeli law allows for police seizures of counterfeit goods as well as for seizure by the customs authorities carried out at points of entry into Israel, as noted in 3.9 Border Measures to Tackle Counterfeit Pharmaceuticals and Medical Devices.

As a general rule, INN – that is, international non-proprietary names of pharmaceutical substances – are ineligible for trade mark registration, as they should be “kept open to the trade”. A trade mark lacking distinctive character in light of the pharmaceuticals or medical devices for which it is designated would also be ineligible for protection and the same would be true for trade marks that stand against public policy in Israel. Such would also be the case where a given trade mark might create confusion with another, earlier trade mark – confusion that could be particularly harmful where pharmaceuticals are concerned.

Where a trade mark is used in a genuine matter, such use is permitted as long it is made in good faith. Also recognised in Israeli trade mark law are the permissibility of parallel importation and the doctrine of global exhaustion. However,  the courts noted that ‒ in order for exhaustion to take place ‒ the owner of the trade mark in both Israel and the territory from which the exhausting product was purchased would have to be the same person, otherwise it could amount to trade mark infringement.

IP protection is available in Israel for the trade dress or design of pharmaceuticals and medical devices, including tablets, medical devices, and their packaging.

Protection may be obtained through trade mark registration, such as registration of 3D marks concerning unique tablets, medical devices, and packaging shapes or 2D trade marks for the graphical elements of the packaging. Unregistered, well-known trade marks are protected as well.

Registrations of industrial designs are also available in the appropriate circumstances, in accordance with the Designs Law of 2017. In order for it to be eligible for protection, the design must be new and have a unique character. However, if the appearance of a product or part of a product is dictated solely by the product’s function, it cannot be registered. Protection for unregistered designs is also available, but it is limited in scope.

Finally, protection can also be provided through the tort of passing off, which prevents misappropriation of the goodwill attached to either the manufacturer or the preparation.

Israeli law allows for a fairly short marketing exclusivity (six to six-and-a-half years) for new chemical entities (NCEs). During this term, the MoH will not issue marketing approval in Israel for a new drug containing the active moiety of an NCE (the registration of which is based on confidential data – safety and efficacy data – filed for a previous drug containing the NCE).

As for biologics, Israeli law only mentions NCEs when discussing marketing exclusivity, which has led the Israeli MoH to adopt the view that biologics do not enjoy marketing exclusivity. This issue has yet to be resolved through judicial review.

The pandemic saw the MoH introduce several relaxations in relation to the commercialisation or distribution of medicines and medical devices. Among other things, the MoH allowed applications related to the approval of pharmaceuticals to be filed via email and permitted private pharmacies to dispense prescription medicine based on copies of prescriptions rather than requiring the originals. The MoH also approved the COVID-19 vaccines for use in Israel immediately after they were issued approval in the USA, as well as expedited the approval of medicines and rapid antigen kits.

Between March and April 2020, the MoH released a series of announcements outlining changes to the conduction of clinical trials during the pandemic. Among other things, the MoH allowed applications to be filed via email, to deliver the trial’s products directly to patients’ homes, to carry out treatments at alternative venues, and to administer tests at the homes of patients. Most of these measures were rescinded in 2021, and no special regulation was issued with regard to COVID-19 treatments or vaccines.

During the pandemic, the MoH used the existing pathway in the Pharmacists’ Regulations to provide non-registered medicine in Israel. According to this pathway, a given pharmaceutical may be imported to and used in Israel even if it was not previously registered with MoH ‒ subject to a physician confirming that the pharmaceutical in question is essential, that no alternative is available in Israel, and that the patient has consented to use the unregistered pharmaceutical.

The authors are unaware of any simplification or flexibility introduced in relation to obtaining required certifications owing to COVID-19.

During the height of the pandemic, the Minister of Commerce did – from time to time – place restrictions on the exportation of certain goods necessary to test for COVID-19 and treat those who have contracted it.

During the height of the pandemic, the MoH instructed HMOs to prefer the provision of healthcare services remotely, either via telemedicine or videoconference. The MoH also introduced a circular set to make it easier for patients to obtain services remotely.

Under Sections 104 and 105 of the Patents Law, the Israeli government may allow the exploitation of a patent-protected invention if it has been found that it is necessary to do so to protect the State of Israel or to provide essential services. This power was first used in March 2020, when approval was given to exploit three Israeli patents owned by AbbVie in order to import generics of its antiretroviral medication KALETRA ‒ which was then believed to be of use in treating COVID-19 ‒ to Israel.

Under the Patents Law, when the power and the above-mentioned sections are exercised, the patent owner is entitled to be notified regarding the government’s decision and to obtain royalties for the exploitation made.

In 2023, the Vaccine Injurees Insurance Law of 1989 was amended to cover those persons who suffered injuries as a result of being vaccinated against COVID-19. No liability exemptions were introduced regarding COVID-19 vaccines or treatments.

The authors are unaware of existing provisions used or new provisions introduced to allow the requisition or conversion of manufacturing sites owing to COVID-19.

While the pandemic has led to certain public procurements being conducted without the statutory tender process, the system itself has not changed.