This country-specific Q&A provides an overview of Pharmaceutical Advertising laws and regulations applicable in Israel.
What laws are used to regulate advertising on medicines in your jurisdiction?
The Pharmacists Regulations (Preparations) 1986 and the Pharmacists Regulations (Sale of Preparations Without a Prescription, Outside a Pharmacy, and Not by a Pharmacist) 2004 (hereafter: General Sale List Regulations- GSL Regulations) are the laws that specifically regulate pharmaceutical advertising in Israel. Other general advertising laws also relevant are Consumer Protection Law 1981 and related regulations.
There are also several Ministry of Health Rules. The main rules are Rule 24/04 – Advertising Preparations (last updated in March 2020), Rule 134 – Raising Disease Awareness, Rule 137- Rules for Improving the Use and Compliance with Prescribed Medicinal Treatment Using Non-Commercial Information, Rule 49- Distribution of Leaflets to Doctors/Consumers and Special Information on Preparations, and Rule 13/2018 on Commercial Engagements by Medical Institutions.
Finally, there are also advertising rules enacted by the National Second Authority for Television and Radio.
Are there any self-regulatory or other codes of practice which apply to the advertising of medicines? a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)? b) What is the legal status of the self-regulatory codes?
The 2014 Joint Code of Ethics between the Israeli Medical Association and The Representative Organizations of the Pharmaceutical Companies Active in Israel (hereafter: Joint Ethics Code). regulates pharmaceutical advertising. The main representative organization party to the Code of Ethics is Pharma Israel.
a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)?
The code applies to all members of Pharma Israel which includes most of the large innovative pharmaceutical companies that operate in Israel. The code also applies to Israeli physicians that are members of the Israeli Medical Association.
b) What is the legal status of the self-regulatory codes?
The code does not have binding legal status. However, it can serve as a guide in legal proceedings.
Is there a statutory or generally accepted definition of “advertising”? a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example? b) Does the definition apply equally to all target audiences?
a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example?
The following definitions for advertising are provided:
In the Pharmacists Regulations (Preparations) advertising is defined as “providing information in writing, through the media or by any other means” (Section 1).
In the GSL Regulations an advertisement is defined as “publication by speech, in writing, in print, or by means of other media that an interested party makes in the marketing of a non-prescription medicine or made on its behalf, and directed to either all or part of the public” (Section 1).
The Pharmacists Regulations (Preparations) definition is also found in Ministry of Health (MOH) Rule 24/04, 134, and 137.
These general definitions of advertisement apply to all potential forms of advertisement.
A pharmaceutical company is allowed to have a list of its prescription drugs and a link to their updated patient information leaflet on its website. The company can also provide a link to the MOH drug price list (MOH Rule 137 Section 3.1.1). Any reference to prescription drugs can only include the name of drug, the names of the active ingredients, the type of medicament, the mode of administration, the drug’s indications as approved by the MOH, the criteria based on which the drug is approved for use by the National Healthcare Insurance, and the fact that it is a prescription drug (Rule 24/04 Section 5.1).
A doctor’s leaflet as approved by the MOH must be provided to all doctors and pharmacists in Israel. A pharmaceutical company can satisfy this requirement by publishing the doctor’s leaflet on the MOH website. The doctor’s leaflet can also be published in a professional journal (Regulation 49, Section 3.4). A pharmaceutical company can also send “special” MOH approved letters, such as “Dear Doctor Letters” (Regulation 49, Section 3.5).
b) Does the definition apply equally to all target audiences?
The definition is general and applies to all target audiences. However, as detailed below, disease awareness campaigns and other information can be provided to patients and doctors.
Are press releases regarding medicines allowed in your jurisdictions, and if so what are the restrictions on these (bearing in mind the target audience)?
The MOH has issued guidelines for contact with journalists. Only professional, fact based and balanced information, that has medical importance can be provided to a journalist. Further, such information can only be provided when there is a public justification for publishing the information, and the information is not commercial in nature.
A journalist can be invited by a pharmaceutical company to a scientific conference, and the journalist’s participation can be funded by the pharmaceutical company. However, the journalist cannot receive any direct or indirect consideration for journalistic activity. Prior to sending a journalist to a conference the pharmaceutical company must notify the journalist of the rules against advertising prescription drugs, provide the journalist with a copy of MOH Rule 137 and Pharmaceutical Regulation- Preparations Regulation Number 28, instruct the journalist not to publish pictures of prescription drugs, and to include a disclosure that the journalist participated in conference at the pharmaceutical company’s invitation. The pharmaceutical company must document the journalist’s agreement to comply with the above rules. If the company follows the rules, it is not responsible for any breach by the journalist. The pharmaceutical company can also invite journalists to a drug launch event.
If a journalist reaches out to a pharmaceutical company the information provided by the pharmaceutical company cannot be intended to encourage the public to ask doctors to prescribe the drug. The information can relate to MOH approved drugs or drugs in the process of being approved by the MOH but cannot relate to non-approved drugs or comparisons between the drug and other drugs. The company’s designated pharmacist must approve the information provided. (MOH Rule 137 Section 3.8-3.9, also see MOH Rule 134 Appendix 2).
Are there any processes prescribed (whether by law or Codes of Practice) relating to the approval of advertising of medicines within companies?
As mentioned above information provided to a journalist must be approved by the company’s designated pharmacist. Also see above regarding inviting a journalist to a scientific conference (See Response to Question 4).
Disease awareness campaigns must be approved as compliant by a committee consisting of the company’s designated pharmacist, marketing director, legal advisor and compliance officer. The committee must review the campaign at least once a year to ensure continued compliance (MOH Rule 134, Section 3.5).
Additional information provided by drug companies to patients prescribed prescription drugs to improve patient compliance and encourage appropriate use of a drug must be reviewed and approved by the company’s medical director (appointed pharmacist) (MOH Rule 137, Section 3.2.4)
The Joint Code requires sales material disseminated by a pharmaceutical company be approved by a professional in the pharmaceutical company (section 94).
Do companies have to have material approved by regulatory bodies prior to release?
Patient and doctor information leaflets must be approved by the MOH (Pharmacists Regulations- Preparations Regulation 20-21, and MOH Rule 49 Section 3.2, 3.4).
Extraordinary information that a company needs to send to medical professionals (e.g. doctor) or patients must be pre-approved by the MOH prior (MOH Rule 49 Section 3.3, 3.5).
Drug companies must notify the MOH of disease awareness campaigns and must obtain pre-approval for an AIDS disease awareness campaign or for campaigns in relation to a disease for which there is only one MOH approved treatment (MOH Rule 134, Section 3.1.5).
Advertisements for Over-the-Counter (OTC) drugs must be approved by the Ministry of Health. One exception to this rule is if the advertisement is published in a medical journal. Another exception is if the advertisement includes a picture of the drug or its packaging containing the brand and generic name of the drug, its strength, its mode of administration, its amount, and its approved indications, and warnings to consult with a doctor or pharmacist prior to use and to consult the product information leaflet. (GSL Regulations, Section 17, Rule 24/04, Section 5.3)
Any information provided to medical professionals at a Medical Institution must be approved by the head of the Institution or a person designated by the head of the Institution to undertake the review. However, full scientific peer reviewed articles or regulatory documents can be provided to medical professionals without prior approval. However, they must be provided for review by the head of the Institution or a person designated by the head of the Institution to undertake the review (MOH Rule 13-2018 Section 14.4)
Is comparative advertising for medicines allowed and if so, what restrictions apply?
This is only relevant for the advertising of OTC drugs. Comparisons are allowed only when the medicines contain the same active ingredient, and the comparison is approved by the MOH. Comparisons can be approved if they are based on scientific studies published in recognized professional journals that relate to equivalent parameters. Price comparisons can also be approved by the MOH (GSL Regulations Section 20).
Is it possible to provide information on unauthorised medicines or unauthorised indications? Is it possible to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals, or to send information to healthcare professionals?
Advertisement of unauthorised medicines or indications is not allowed.
However, additional updated information substantiated in professional literature that does not contradict the product information leaflet can be provided to medical professionals (doctors, nurses, pharmacists). The information cannot be intended to influence or encourage a use that is not in accordance with the drug’s MOH registration. Providing this information on a website is only allowed if the website requires medical professionals to register and login with a password. (MOH Rule 137 Section 3.1.2).
The information in medical literature provided cannot relate to unapproved indications, and the information provided must state the approved indications and reference the product’s patient and/or doctor information leaflet (Pharmacists Regulations- Preparations Section 28a,b). However, information regarding a drug for which an approval application has been submitted but has not been approved, or an applied for but as yet unapproved indication, can also be provided to medical professionals in the above manners (MOH Rule 24/04, Section 5.2.3).
Finally, such information can only be provided to other treatment professionals (e.g. nutritionists, physical therapists) if approved by the MOH (MOH Rule 137 Section 3.1.2).
The Joint Ethics Code allows pharmaceutical companies to provide scientific information to doctors on unapproved drugs to doctors. The pharmaceutical company must inform doctors of the regulatory status of the drug (Section 91).
Please provide an overview of the rules that apply to advertising to the general public for prescription only medicines and over the counter medicines, an indication of the information that must or must not be included.
The advertising of prescription medicines to the general public is not allowed. However, additional information to improve patient compliance and encourage appropriate use of a drug can provided to patients with a prescription for the medicine website in a manner similar to the provision of information to doctors. (MOH Rule 137 Section 3.2.4).
Disease awareness campaigns are also allowed in Israel, but they cannot mention the name of any prescription medicines. The campaign must relate to information that is accurate, updated, broadly supported by the medical literature and comprehensive. Further, such campaigns cannot promote the use of the drug or be directed to minors. The campaign should be directed to disease awareness but can provide a literature review of all available treatments. The term “treatment” cannot be used in short form messages and at the end of a publication must direct the public to consult with a doctor without mentioning the term “treatment” (e.g. banners, outdoor advertisements). Treatments cannot be singled out but all relevant treatments can be mentioned. Comparisons between treatment are also not allowed, and only questionaries that are scientifically accepted or approved by professional organizations can be used. The pharmaceutical company’s support for the disease awareness campaign must be mentioned. (MOH Rule 134 Sections 3.1, 3.2). The Joint Ethics Code also allows for disease awareness campaigns (Section 93).
Advertising of OTC drugs, as opposed to prescription drugs is allowed in Israel. Such advertising must be in accordance with the approved indications, in a manner that is not intended to mislead or cause panic or be intended to encourage self-use by minors, and must contain notice of the active ingredient and a recommendation to consult with a doctor or pharmacist, and the to review the product’s information leaflet.
Additionally, the advertisement must include the name of the medication, the name of the active ingredient (in cases there are three or more active ingredients in audio advertisements reference can be made to the product information leaflet), a picture of the product’s packaging (except in audio advertisements), a reference to review the product information leaflet prior to use, at least one approved indication must be mentioned, and any additional information required by the MOH (e.g. contraindications, (GSL Regulations, Section 17a, Rule 24/04 Section 5.3)
Finally, the MOH prohibits any publication of non-prescription drugs together with prescription drugs (MOH Rule 24/04 Section 5.1).
Are there any restrictions on interactions between patients or patient organisations and industry (e.g., consultation, sponsorship)? If so, please describe those briefly.
Drug companies can provide funding or sponsorship to a patient or caretaker organizations for drug awareness campaigns and to improve compliance. These organization can must have the freedom to publish any information they desire, must only relate to MOH approved doctor/patient information leaflet in relation to prescription drug, and must disclose the pharmaceutical company sponsored the information as a non-contingent donation. (MOH Rule 137 Section 3.10, MOH Rule 134, Section 3.1.3).
Further, the relationship between the patient organization must be codified in a written agreement. The agreement must state that the organization is aware of the requirement to avoid advertisement under Regulation 28 and MOH Rule 134 and that the sponsor has no control over the content or manner of publication (MOH Rule 134, Section 3.1.3)
Which information must advertising directed at healthcare professionals contain, and which information is prohibited? For example can information about clinical trials, or copies of journal be sent?
See answer to question 8 above.
The Joint Ethics Code also notes that information provided to healthcare professionals.
May pharmaceutical companies offer gifts to healthcare professionals and are there any monetary limits?
Healthcare professionals that work at Medical Institutions cannot accept any gifts (MOH Rule 13-2018, Section 14.6). According to the Joint Ethics Code doctors can accept nominal gifts (Section 50).
Are pharmaceutical companies allowed to provide samples to healthcare professionals?
Healthcare professionals that work at Medical Institutions can only accept any samples for demonstration if pre-approved by the designated reviewer at the Medical Institution. A healthcare professional can only keep samples in the office if the samples cannot be obtained in a different manner and pre-approval is obtained from the MOH Supreme Committee on Commercial Engagements (MOH Rule 13-2018, Section 14.3). The Joint Ethical Code also notes that doctors cannot receive or give consideration for samples, provide samples in commercial quantities, and that samples must be labelled as such (Sections 57-59).
Is sponsorship of scientific meetings or congresses and/or attendance by healthcare professionals to these events? If so, which restrictions apply? Do additional restrictions apply to events taking place abroad?
Companies can sponsor scientific meetings in Israel under certain conditions. The pharmaceutical company cannot organize the conference. The support can be used to support speakers, participants, and organization of the conference. The support cannot be used for non-professional activity (e.g. entertainment, hikes, lodging on days on which there are no professional activities). The organizer of the conference (e.g. medical institution, recognized professional organization) should reach out to at least three companies for support of the conference. The support must be approved by an officer in the organization conducting the conference (MOH Rule 13-2018, Section 11, also see Joint Code of Ethics Sections 11-26).
The head of a Medical Institution can approve the sponsored participation of a healthcare professional in a conference under certain conditions. First, at least 75% of activities are related professional matters. Second, support is not provided for days that do not have professional activity. Lastly, the conference does not have any entertainment. (MOH Rule 13-2018, Section 11).
A company can sponsor the participation of a healthcare professional in a conference outside of Israel. The sponsor must provide the funds directly to the conference or the hotel and no payments can be made to the participant. Payment for flights can only be made by providing general funding to a Medical Institution for participating in conferences.
In cases in which the Medical Institution is provided funding, the Institution will select a healthcare professional that does not have any connection with the company. The healthcare professional cannot be involved in hospital acquisitions. The conference cannot be intended for marketing purposes or sponsored by only one company. The sponsorship can only fund coach airfare, hotel, meals, conference registration, and trips to and from the airport. Any foreign flights must be as close to the dates of the conference as possible. (MOH Rule 13-2018, Section 12, also see Joint Ethics Code Sections 28-33).
What are the restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies?
Participation by healthcare professionals employed by Medical Institutions is not allowed (see answers to questions 12 and 14, also see Section 52 of the Joint Ethics Code).
Is it possible to pay for services provided by healthcare professionals and if so, which restrictions apply?
Healthcare professionals employed by Medical Institutions can undertake outside work only they receive specific approval from the head of the medical institution. Approval cannot be provided if there is a potential of any conflict of interest MOH Rule 13-2018, Section 13).
The Joint Ethics Code limits any doctor consultant groups to a maximum of 15 doctors, and all doctors must sign consultancy agreements. Doctors can receive payment for services and reimbursement for any expenses (See Sections 63-71)
Are pharmaceutical companies permitted to provide grants or donations to healthcare professionals or healthcare institutions? Does it matter if the grant or donation is monetary or in kind?
Pharmaceutical companies can provide grants or donations healthcare professionals and healthcare institutions. There is no difference between monetary or in kind donations or grants (MOH RULE 13-2018, Section 15, National Insurance Law Section 40a).
The Joint Ethics Code also allows grants to Medical Institutions (Section 51).
Are pharmaceutical companies required to disclose details of transfers of value to healthcare professionals or healthcare institutions? If so, please indicate whether this is a legal requirement or not, and describe briefly what the companies must report and how. Do these transparency requirements apply to foreign companies and/or companies that do not yet have products on the market?
There is a disclosure requirement for foreign and domestic companies if the yearly total provided by the company is greater than 2500 NIS (~700 USD) then the company must report donations to the MOH on once a yearly basis. (National Insurance Law Section 40a).
When if at all with a competent authority have to get involved in authorising advertising? Is advertising on the internet (including social media) for medicinal products regulated, and if so, how? Should companies include access restrictions on websites containing advertising or other information intended for healthcare professionals?
See answers to questions 8 and 9.
Are there any anti-bribery rules apply to communications between pharmaceutical companies and healthcare professionals or healthcare organizations?
All regular anti-bribery rules apply to interactions between pharmaceutical companies and healthcare professionals or healthcare organizations. Section 290-291 of the Israeli Criminal Law relates to bribery of public officials. Section 290 expands the meaning of public officials to any worker in a company that provides a service to the public. Thus, virtually all healthcare professionals in Israel are considered public officials for the purpose of bribery.
What are the rules (whether statutory or self-regulatory) which govern the offering of benefits or inducements to healthcare professionals?
See answers 12, 14, and 15 above.
Which bodies are responsible for enforcing the rules on advertising and the rules on inducement? Please include regulatory authorities, self-regulatory authorities and courts.
The laws can be enforced by the MOH and courts. There is also enforcement capabilities under the Joint Code of Ethics creates a joint enforcement forum combining members of industry and doctors.
On what basis and before which bodies or courts can companies initiate proceedings against competitors for advertising infringements?
Companies submit a complaint to the MOH, the Joint Enforcement Forum, or direct action in the courts based among others on Consumer Protection Law or Commercial Torts Law.
What are the penalties, sanctions or measures that regulators or courts can impose for violating medicines advertising rules and rules on inducements to prescribe in your jurisdiction?
Courts can impose sanctions of up to 150,000 NIS (~45,000 USD) for a violation of the rules on advertisements by an individual and 300,000 NIS (~90,000 USD) for a violation by a company. Under a temporary article of the Pharmacist’s Ordinance, violators of the GSL advertisement regulations is subject to up to six months in prison.
Inducements can be handled under anti-bribery legislation. The punishment for bribing a public official is up to seven years imprisonment, up to 1 million NIS fine for individuals, up to 2.2 million NIS for companies, and/or four times the amount of the bribe. Gifts in an amount greater than a nominal value to healthcare professionals also can violate the Civil Service (Gifts) law. The law allows for civil servants to be fined an amount up to three times the worth of the gift.
What is the relationship between procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts/government competent authorities?
Together with the power to approve advertisements the MOH notes that it can take action against unapproved advertisements. The MOH can act to order the advertisement’s removal and ordering the publication of a clarification. As noted above, actions that can lead to fines or imprisonment can be initiated by the MOH (MOH Rule 04/24, Section 5.8).
According to the Joint Ethics Code the Ethics Forum can order the pharmaceutical company to take action to rectify the violation (See Code Appendix).
Are there any recent enforcement trends in relation to pharmaceutical advertising in your jurisdiction? Please report any significant (publicly known) enforcement actions in the past two years.
There are no recent enforcement trends.
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