FAQs – Pharmaceutical Industry Laws in Israel
What are the major pharmaceutical laws and regulatory bodies in ISRAEL?
The main legislation relating to pharmaceuticals in Israel is:
- The Pharmacists Ordinance (New Version) 1981, which governs the manufacture, selling, prescribing, importation, and registration of medicinal products, as well as data exclusivity provisions.
- The Pharmacist Regulations (Medical Preparations) 1986, which govern the selling, prescribing, importation, and registration of medicinal items, as well as pharmacovigilance and recall provisions.
- The Pharmacist Regulations (Good Manufacturing Practice) 2008, which governs the manufacturing, importation, and recall of pharmaceuticals.
- The Goods and Services Price Surveillance Act of 5756-1996.
- 5761-2001, Order for the Supervision of Goods and Services Prices (Maximum Prices for Prescription Preparations).
- 5761-2001 Order for the Supervision of Goods and Services Prices (Application of the Act to Preparations).
- The Ministry of Health (MOH) Pharmaceutical Administration is the governing body in charge of pharmaceuticals in Israel. It is made up of the following bodies:
- The Institute for Standardization and Control of Pharmaceuticals (ISCP), which is in charge of ensuring the quality of pharmaceuticals.
- The Department of Preparations Registration, which is in charge of registering pharmaceutical products.
- The Import of Pharmaceuticals and Drugs Department, which is in charge of medicinal product importation.
- The Pharmaceutical Monitoring Section, which is in charge of approving medicinal product labelling and packaging.
The Department of Pharmacovigilance and Drug Information, which is in charge of ensuring the safety of drug treatment
- Pharmaceutical facilities in Israel, among other items, are under the purview of the Pharmaceutical Administration.
- Obtaining and inspecting pharmaceutical and medical device licenses.
- Observing human clinical trials
- Defending against prescription fraud.
- The key aim of the Pharmaceutical Administration is to ensure that all medical preparations sold in Israel meet the required safety, consistency, and efficacy requirements. The Pharmaceutical Administration is also in charge of implementing the rules that govern its operations.
- Section 1 of the Pharmacists Ordinance defines the terms preparation and therapeutic medication as any type of a substance or combination of substances that is one of the following (except blood or blood portion obtained from a human being that is intended to be used in its natural physiological form and has not undergone significant processing):
- It has properties for curing, preventing, or treating a disease in a person or animal, or it is advertised as having such properties.
- By exerting a pharmacological, immunological, or metabolic operation, it induces (or is administered to a human being or animal for the purpose of causing) regeneration, substitution, reparation, or a change of a physiological action throughout the body.
- It is given to or may be given to a person or an animal for the purpose of medical diagnosis.
What is the national health-care system's framework, and how is it funded? Explain how drugs are inserted into the system or how they are supplied in the market ?
The following are the major features of Israel's national healthcare system:
- Membership in one of the four Israeli Sick Funds is required.
- Israeli citizens must pay National Health Insurance to the National Health Institute, which then distributes the funds to the Sick Funds (however, non-payment by an individual would not affect the Sick Fund's obligation to provide that person with all medical care to which he or she is entitled).
- A national "Health Basket" that is revised every year to reflect emerging medical products and technology and outlines the programs that Sick Funds must offer to their members.
The funding for the National "Health Basket" derives from three sources:
The National "Health Basket" is funded by three sources: national health insurance payments, Sick Funds' "participation" payments (derived, for example, from direct payments to the Sick Funds from members for complementary health insurance programs), and MOH budget payments.
A proposal to add a new medication or medical technology to the National Health Basket may be made by any public or private agency (for example, patients, patient organizations, doctors, or pharmaceutical companies).
Drugs that have been licensed or that have been submitted for approval and are expected to be accepted within the year will be included in applications.
Drugs that have been licensed or that have been submitted for approval and are expected to be accepted within the year will be included in applications. If a medication is included in the new health basket, it will receive priority review. As a result, the regulatory mechanism could be improved.
On the recommendation of the Public Committee for the Expansion of the Health Services Basket, new medicines and medical innovations are applied to the National Health Basket. This committee advises the Ministry of Health on which medicines and innovations should be included in the basket (considering budgetary constraints).
Following the approval of the Health Council and the Minister of Finance's agreement, those recommendations must be approved by the government.
Pharmaceutical companies typically discuss costs with the Ministry of Health as part of the decision to add a new drug or medical technology to the Basket.
The Sick Funds are also used by the majority of Israelis to pay for additional health facilities, such as medications, that are not covered by the National Health Basket. A growing number of Israelis have private health insurance schemes, which cover a variety of medications and medical facilities (some of which are not covered by the National Health Basket or the SHS's complementary services).
Patients that need medications or medicines that are not covered by the National Health Basket may petition their sick fund's exceptions committee, and the decision can be appealed to a state labour court.
Is there a set of mandatory standards for the protection of pharmaceutical products?
- Under the Good Manufacturing Practice Regulations 2008, the following mandatory conditions for medicinal product protection apply:
- • Any allegation about a defect in the nature of a medicinal product must be investigated and registered by the quality assurance (QA) department of the MIA holder. Any defect that could result in the medicinal product's production and availability being limited or its recall from the market must be reported to the MOH by the MIA holder.
• When a registration holder, MIA holder, or the Director General of the MOH is informed that a medicinal product could endanger public health, the registration holder, MIA holder, or the Director General of the MOH must take some action that allows it to monitor batches of medicinal products and marketed products for the purpose of recalling a defective medicinal product at the direction of the MOH Director General, or in the event that a medicinal product could endanger public health.
• The owner of a company that manufactures or imports APIs, as well as a pharmaceutical establishment that stores or transports APIs, must take steps to allow it to track batches of marketed APIs for the purpose of recalling defective batches from the market if the substances threaten public health, or at the direction of the MOH's Director General. When the Director General or the owner of a company that manufactures or imports APIs orders the marketing of an API to be halted, it must be done right away.
If a marketer of a pharmaceutical product or API, the owner of a pharmaceutical establishment, or the owner of a business manufacturing or importing pharmaceutical products or APIs receives notice that marketing must cease, the product/API must be returned to the entity from which it was received, unless the Director General of the MOH orders otherwise.
A defect in a medicinal product must be reported to the MOH GMP department immediately, and an investigation and risk assessment report must be sent to the GMP department within 48 hours, according to MOH Procedure No. PUB-003/08 (June, 2019). (if the investigation and risk assessment cannot be completed promptly, intermediate reports must be filed within this timeframe). Furthermore, before the MOH makes a decision, the suspicious product's inventory must be quarantined.
What rules govern the advertising and promotion of medicinal products, as well as the distribution of samples, and how are advertisements and promotional activities regulated?
Legislation and regulatory authority
• Pharmacist Regulations (Preparations) 1986 is a piece of legislation that governs the advertisement of pharmaceutical products.
• Pharmacists Regulations (Sale of a product not in a pharmacy or by a pharmacist) (Sale of a product not in a pharmacy or by a pharmacist) (Sale of a product not in a pharmacy or by a pharmacist)
• Procedures of the Ministry of Health.
• Television and Radio (Ethics in TV Commercials) Rules of the Second Authority, 1994.
• Ethics in Radio Commercials, Rules of the Second Authority for Television and Radio, 1999.
The MOH is the primary regulatory body in charge of implementing the restrictions and laws governing medicinal product ads. In addition, advertisements on television and radio are controlled by the Second Authority for Television and Radio.
The Pharmacists Regulations (Medical Preparations) 1986 describe advertising as the dissemination of information in writing, through the media, or through some other means. Given this broad definition, the regulations and procedures governing medical preparation ads cover a wide range of advertising practices in all media and platforms.
The MOH must authorize any advertisement of medicinal products in advance. It is illegal to advertise prescription-only drugs (POMs) to the general public. Advertising of prescription and non-prescription drugs to health care practitioners is allowed if it emphasizes the approved indications. Advertising non-prescription drugs to the general public is permitted under strict conditions, including that the details in the advertising be right, reliable, concise, and consistent with the product's accepted indication. Comparative ads are only permitted between goods with similar APIs and where a sufficient and consistent basis for comparison exists.
The MOH treats advertising to the general public on the internet, including social media platforms, in the same way it treats advertising on any other platform. A registration holder may view a list of pharmaceutical products registered in its name on its website under MOH Procedure No. 137 (2015).
Does Israel state's privacy and data security laws have an effect on pharmaceutical regulation?
In Israeli law, there is a strong emphasis on maintaining a person's privacy. In terms of a patient's privacy, the Patient Rights Act of 1996 imposes a general obligation on medical professionals (and other therapists) and employees of health facilities to keep confidential any information about a patient that they obtain in the course of their duties or jobs. The Act also states that a medical practitioner/therapist or the director of a health system must take reasonable steps to ensure that staff working under their supervision keep patient details confidential.
Furthermore, the Privacy Protection Act of 1981 imposes a general obligation (that extends to commercial companies) not to publish health-related information.
Databases containing personal medical information or genetic information must follow strict security protocols under the Privacy Protection Regulations (Information Security) 2017.
The Privacy Protection Regulations (Transfer of Data to Databases Outside the State Borders) 2001 provide for the transfer of personal data from an Israeli database to a database outside Israel under strict conditions.
The duty to protect a patient's privacy is also outlined in various MOH Procedures, such as:
- MOH Procedure (No. 14 (2016)), which states that the Helsinki Committee will not approve a clinical trial in human subjects unless the trial program includes provisions to protect the privacy of trial participants and the confidentiality of data collected in the trial.
- MOH Procedure (No. 6 (2013)), which states that adverse reaction reports need not contain identifiable information about the patient, and that information in follow-up reports does not compromise the patient's privacy.
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