General - Medicinal Products

General – Medicinal Products

1.1 What laws and codes of practice govern the advertising of medicinal products in your country? Advertising of medicinal products in Israel is governed by a combination of laws, regulations and ethical codes. Though the Consumer Protection Law – 1981 (“CPL”) and some of its regulations do not specifically mention pharmaceutical advertisements

, they outline general consumer protection restrictions which include restrictions relating to the sale and advertisement of pharmaceuticals. The CPL prohibits misleading consumers as to the quality and substance of goods and services, which is often the case with “miracle” beauty and health products. The Consumer Protection Law (Advertisements Targeted at Minors) – 1991 prohibits advertisements which encourage minors to consume pharmaceuticals or endanger their health. Advertising on television, including pharmaceutical advertisements, are strictly regulated. The Second Television and Radio Authority Rules (Television Advertising Ethics) – 1994 and the Communication Rules (Bezek and Broadcasting) (Advertisements, Services and Sponsorship Broadcasting on designated Channels) – 2004, set specific rules and guidelines relating to the advertisement of pharmaceuticals. The former Rules relate to private television stations (in contrast to state/national television) and the latter Rules relate to private television broadcasted through cable and satellite. Advertising in Radio, inclusive of pharmaceutical advertising, is governed by the Second Television and Radio Authority Rules (Radio Broadcasting by a Franchisee) – 1999 and the Broadcasting Authority Rules (Radio Advertisements and Announcements) – 1993. The Pharmacists Ordinance – 1981 and its derived Pharmacists Regulations – 1986, inter alia, set regulations relating to the registration of authorised pharmaceuticals in the Ministry of Health’s Preparations Registry, their production, marketing and advertising. Most doctors in Israel are members of the Israel Medical Association (“IMA”), which sets internal rules and codes of conduct. In 2004 the IMA, combined with Pharma Israel, an association of pharmaceutical companies, signed “The Joint Ethical Convention of the Israel Medical Association and the Medicine Companies Active in Israel” (“Joint Ethical Convention”). Some of the Joint Ethical Convention’s sections relate to advertising.

1.2 How is “advertising” defined? The term “Advertisement” is not defined within all the laws relating to advertising. Some of the relevant laws define advertising as “a message which may promote, directly or indirectly, a product, service, business or any other commercial interest, either in exchange for consideration or without consideration”. An advertisement may include announcements and sponsorship.

1.3 Must advertising be approved in advance by a regulatory or industry authority before use? If so, what is the procedure for approval? Even if there is no requirement for prior approval in all cases, can the authorities require this in some circumstances? Pursuant to the Pharmacists Regulations (Preparations) – 1986, it is prohibited to advertise preparations in the media or non-scientific journals without authorisation by the General Director of the Ministry of Health. In accordance to these Regulations, the Ministry of Health issued “Procedure No. 24” which defines the bureaucratic formalities relating to the prior approval of medical preparation advertisements targeted at the general public. Pursuant to Procedure No. 24, advertisements must be submitted to the Ministry of Health within a set request form. The Ministry may approve/reject and/or amend the request within 21 days after its receipt. Approval is valid for one (1) year subject to renewal. As to advertising on private television, according to The Second Television and Radio Authority Rules (Prior Approval of Advertisements) – 1994, the General Manager of the Second Authority, may determine advertising topics which require prior approval before being broadcasted. In accordance with these powers, it has been determined that pharmaceuticals and all health related advertisements, require prior approval. Moreover, pursuant to The Second Television and Radio Authority Rules (Television Advertising Ethics) – 1994, it is prohibited to broadcast advertisements relating to health, medicine or medical treatment (“health related advertisements”) unless the advertiser provides a medical opinion as to the reliability of the advertisement. Health related advertisements which their proper evaluation demand medical expertise, require prior approval by a Medical Committee whose members are appointed by the Second Television and Radio Authority. Similar rules apply to advertisements broadcasted through cable and satellite television.

1.4 If the authorities consider that an advertisement which has been issued is in breach of the law and/or code of practice, do they have powers to stop the further publication of that advertisement? Can they insist on the issue of a corrective statement? Are there any rights of appeal? Advertisements broadcasted on the private television channels and cable, in breach of the relevant laws, may be cancelled by the Second Television and Radio Authority and the Cable and Satellite Counsel if they consider that the advertisements are in breach of the relevant rules and regulations. Both authorities may request corrective statements. The Consumer Protection Commissioner, empowered by the CPL, enforces the CPL and its regulations. The Commissioner has the right to request that an infringer of the CPL submit a written undertaking to cease the breach or amend the breach by publishing a statement. The Commissioner may further request that a court issue an injunction against a breach of the CPL. Additionally, the Commissioner may request that a court issue a mandatory injunction, which may include a corrective statement. The General Director of the Ministry of Health, in accordance to Procedure 24, has the authority to cancel advertisements which are in breach of the relevant regulations. He may further demand corrective statements and/or the amendment of an advertisement. All the above-mentioned actions and decisions by the appropriate bodies may be challenged before the courts.

1.5 What are the penalties for failing to comply with the rules governing the advertising of medicines? Who has responsibility for enforcement and how strictly are the rules enforced? Are there any important examples where action has been taken against pharmaceutical companies? To what extent may competitors take direct action through the courts? Pursuant to the CPL, misleading and taking advantage of consumers, inclusive of misleading advertisements, are punishable by a fine of up to approximately US$35,000 or a prison term of one (1) year. Empowered by the Second Television and Radio Authority Law – 1990, the Authority has the power to fine infringers of the relevant rules, cease the broadcasting of advertisements and penalise by reducing broadcasting time. The Cable and Satellite Council has similar powers. The rules are often upheld. Competitors often lodge complaints with the relevant authority, alleging breach of the advertising rules and regulations. Decisions rendered by the different authorities may be challenged before the courts. There have been many cases, though not relating to pharmaceutical advertisements, in which parties attacked decisions rendered by the Second Television and Radio Authority. Such attacks usually take place within petitions before the Israel High Court of Justice.

1.6 What is the relationship between any self regulatory process and the supervisory and enforcement function of the competent authorities? Can, and, in practice, do, the competent authorities investigate matters drawn to their attention that may constitute a breach of both the law and any relevant code and are already being assessed by any self- regulatory body? Do the authorities take up matters based on an adverse finding of any self-regulatory body? The competent authorities, such as the Ministry of Health and the Ministry of Commerce and Industry set the relevant regulations and regulatory bodies. The competent authorities can and occasionally do investigate mattes drawn to their attention. Usually the authorities will take up matters which are brought to their attention by complaints (either formal or informal), lodged by the public or by competing companies. Occasionally, the relevant authorities will investigate matters due to their own initiative.

1.7 In addition to any action based specifically upon the rules relating to advertising, what actions, if any, can be taken on the basis of unfair competition? Who may bring such an action? Unfair competition actions are usually relied upon by companies which challenge their competitors before the courts. Unfair competition actions, which are quite common, may be brought by both individuals and companies. Parties challenging their competitors’ advertisements may base their actions on various intellectual property related laws, such as the Trademark Ordinance – 1972. Additionally, tort related laws, such as the Commercial Torts Law – 1999 may be a foundation to such actions.

2 Providing Information Prior to Authorisation of Medicinal Product

2.1 To what extent is it possible to make information available to health professionals about a medicine before that product is authorised? For example, may information on such medicines be discussed, or made available, at scientific meetings? Does it make a difference if the meeting is sponsored by the company responsible for the product? The Pharmacists Ordinance generally prohibits production and marketing of pharmaceuticals not registered in the Preparations Registry. However, there are exceptions and qualifications to this rule. Preparations may be marketed prior their authorisation for research purposes in accordance with rules set by the Minister of Health. The Pharmacists Regulations (Preparations) – 1986 allows the publication of unauthorised pharmaceuticals for medical and scientific research, subject to authorisation by the Ministry of Health’s General Director. The Joint Ethical Convention also prohibits the marketing of pharmaceuticals prior to the proper authorisation. Nevertheless, this prohibition does not negate the right of the scientific community to be updated and made aware of medical and scientific progress. Moreover, this prohibition does not limit providing scientific information relating to pharmaceuticals, including research findings in professional journals, in scientific conventions and in the mass media. When new preparations and/or technology are exposed at scientific conventions, the regulatory status of the product must be disclosed. A pharmaceutical company may sponsor a meeting, provided, inter alia, the sponsorship is properly disclosed and sponsored in a manner which does not breach the relevant laws, regulations and codes.

2.2 May information on unauthorised medicines be published? If so, in what circumstances? Subject to the above-mentioned rules and qualifications, information relating to unauthorised pharmaceuticals may be

published, provided the information is appropriate and detailed.

2.3 Is it possible for companies to issue press releases about medicinal products which are not yet authorised? If so, what limitations apply? As mentioned above, scientific information may be provided in the mass media, inclusive of press releases. However, publications in the media and in publications which are not scientific or professional, must be approved by the General Director of the Ministry of Health.

2.4 May such information be sent to health professionals by the company? If so, must the health professional request the information? Assuming the relevant laws, regulations and codes are observed, there is no prohibition against sending information on unauthorised pharmaceuticals to health professionals nor must the health professionals request the information.

2.5 May information be sent to institutions to enable them to plan ahead in their budgets for products to be authorised in the future? There is no prohibition against sending information of unauthorised pharmaceuticals to institutions, subject to the above-mentioned limitations and qualifications.

3 Advertisements to Health Professionals

3.1 What information must appear in advertisements directed to health professionals? According to the Pharmacists Regulations (Preparations) – 1986, it is prohibited to advertise medical preparations in professional scientific publications, unless the preparations’ authorised medical purpose is clearly stated; preparations conditioned with publications within pamphlets and/or doctors’ pamphlets, must refer to the pamphlets. Additionally, pursuant to the Joint Ethical Convention, information relayed for the purpose of marketing pharmaceuticals may not disguise their primary marketing purpose and must contain: The name of the preparation. The active components. The name and address of the product’s producer or its agents. All the preparation’s traits and characteristics relating to the use of the preparation, inclusive of the preparation’s authorised purpose and primary limitations as depicted in the Preparations Registry. The distributor’s contact details for further information if needed.

3.2 Is it a requirement that there be data from any or a particular number of “head to head” clinical trials before comparative claims are made? Though the Ministry of Health’s Procedure No. 24, which relates to the general public, does not mention “head to head” trials, its rules governing comparative advertisements are worth mentioning. Namely, comparative advertisements must compare between medical preparations with identical active substances. The comparative points must be based on “Peer Review” scientific publications. The compared advertised product may not be represented in a manner which creates an artificial advantage. The Pharmaceutical Department of the Ministry of Health will authorise a comparison after it’s convinced that the comparative bases is appropriate. Though “head to head” trials are not specifically mentioned in the Joint Ethical convention, it states that information disseminated for marketing purposes must be based on professional, updated and valid information and must not disguise the products’ true substance. The data must be based on the Doctor’s Pamphlet as authorised by the Ministry of Health and/or updated medical knowledge. Scientific facts and figures which support claims relating to the preparation, must be made available, if requested by those in the medical profession. Post marketing research must be conducted in a scientific and professional manner. Printed material for marketing purposes, based on published research, must be clearly cited. Quotations taken from medical literature must be accurate.

3.3 What rules govern comparator advertisements? Is it possible to use another company’s brand name as part of that comparison? Would it be possible to refer to a competitor’s product which had not yet been authorised in your country? Though the CPL does not specifically prohibit comparative advertisements, it provides extensive disclosure obligations and prohibits misleading consumers, inclusive of health professionals. Thus, when comparing products, one must take care not to mislead. This applies to all goods and services, including pharmaceuticals. Similar rules exist in the Joint Ethical Convention. The Second Television and Radio Authority Rules (Television Advertising Ethics) – 1994, allow comparative advertising, provided, the compared products are similar and the bases of comparison identical. The points of comparison must refer to facts which can be substantiated and cannot be presented in a manner which creates an artificial advantage. It is prohibited to claim that a product is generally superior based on limited comparison. Pursuant to the Pharmacists Regulations (Sale of Non-Prescription Preparations Outside Pharmacies and not by Pharmacists) – 2004 and Procedure No. 24, comparative advertisements will not be authorised unless the compared basis is equal and the comparison relies on scientific comparative research which was published in known professional journals. Further, the drugs’ active ingredients must be identical. The General Director of the Ministry of Health may authorise comparison between the prices of different preparations which contain the same active substances, provided the comparison does not contempt the competitor. According to the Israel Supreme Court ruling in Ariel McDonald Vs. McDonald’s Ltd. et al, one may use the trademark of a competitor in a comparative advertisement. However, one may not use a competitor’s trademark merely to diminish its competitor without comparison. There is no specific law against comparing an authorised product with a non-authorised product, provided the comparison is not in breach of the above-mentioned rules and regulations.

3.4 What rules govern the distribution of scientific papers and/or proceedings of congresses to doctors? Pursuant to the Joint Ethical Convention, scientific literature maybe distributed only to hospital libraries and communal clinics and not to individuals of the medical profession. Printed material designated for marketing purposes must be clearly represented as such.

3.5 Are “teaser” advertisements permitted, which alert a reader to the fact that information on something new will follow (without specifying the nature of what will follow)? “Teaser” advertisements are allowed provided they are not in breach of the above-mentioned rules and regulations. In the case of Bercowitz Vs. Esta Lines, the Jerusalem District Court recently ruled that advertisements must be decent, fair and represent facts in a truthful manner. The use of “teasers”, designed to lure consumers only to discover that the offered product differs from the represented product, is illegal. Additional information and qualifications, must be apart of the advertisement and cannot be provided at a later stage.

4 Gifts and Financial Incentives

4.1 It is possible to provide health professionals with samples of products? If so, what restrictions apply? First and foremost, it should be noted that pursuant to Section 41 of the Doctors Ordinance – 1976, doctors must behave in an appropriate manner, suitable for a doctor. Similar laws apply to dentists and pharmacists. Thus, the issue of gifts, in extreme cases, may be governed by these general conduct clauses. Moreover, according to Section 290 (a) of the Israel Penal Law – 1977, “a public servant who accepts a bribe in return for an action related to his position, shall be liable to seven years imprisonment or seven years and a fine of ten thousand Liras”. Section 293 states that a bribe need not be in the form of money, rather, may also take the form of money equivalent or a benefit, if the bribe was given to induce or to result in favouritism or prejudice. Pursuant to Section 291, the bribe provider is also liable to penalties prescribed by the Penal Law. As decided in the case of The State of Israel Vs. Dr. Vladimir Yakirevich, a doctor employed by a public hospital is considered a public servant. Moreover, the National Economy Regulation Law (Legislation Amendments for Achieving the Budget Objectives and Economic Policies of the 2006 Fiscal year) – 2006 (“Regulation Law”), has amended the Public Service Law (Gifts) – 1979, in a manner that redefines “public servants”. Following the amendment, a “public servant” will include employees of public hospitals and healthcare service organisations. For more information, see section

9. The above-mentioned two (2) paragraphs should be taken into consideration while reading the relevant questions throughout the entire chapter. The Joint Ethical Convention allows supplying samples of medical preparations only to those empowered to provide a medical prescription, for the purpose of introducing the preparation, or to enable the receiver to obtain usage experience relating to his/her work. It is prohibited to provide samples in commercial quantities and in any event, the distributed samples must adhere to the internal regulations of the medical institution in which they are being distributed.

4.2 Is it possible to give gifts or donations of money to medical practitioners? If so, what restrictions apply? The Joint Ethical Convention outlines the following: It is prohibited to provide financial and material benefits to health professionals, designed to influence them in registering medical products. It is allowed to provide free sale promotion products which are not significant in value, provided the gifts are not related to services provided by the health professionals or for the benefit of their patients. A doctor will not receive gifts, inclusive of insignificantly valuable gifts, in return for registering medicine or prescribing a medical examination. A doctor will not condition the use of a certain technology in return for benefits. A doctor will not receive gifts, money or the equivalent of money, such as: vacation vouchers, purchasing vouchers, etc. A doctor may receive a gift of insignificant value which is relevant to the doctor’s work, as a courtesy or for the purpose of providing information, gifts such as: office equipment, signs, anatomy posters, etc.

4.3 Is it possible to give gifts or donations of money to institutions such as hospitals? Is it possible to donate equipment, or to fund the cost of medical or technical services (such as the cost of a nurse, or the cost of laboratory analyses)? If so, what restrictions would apply? The Joint Ethical Convention allows receipt of valuable gifts such as: portable computers, digital cameras, computers, valuable professional literature, etc., provided the gifts are given to wards/clinics for the purpose of scientific research and they are registered in the inventory.

4.4 Is it possible to provide medical or educational goods and services to doctors that could lead to changes in prescribing patterns? For example, would there be any objection to the provision of such goods or services if they could lead either to the expansion of the market for or an increased market share for the products of the provider of the goods or services? Subject to the above-mentioned laws and regulations relating to gifts, bribes and general conduct clauses, there are no specific laws or regulations which outlaw the above.

4.5 Do the rules on advertising and inducements permit the offer of a volume related discount to institutions purchasing medicinal products? If so, what types of arrangements are permitted? It is not prohibited to offer volume related discounts, provided the discounts are not “gifts” and adhere to the above-mentioned rules and regulations. Pursuant to The Pharmacists Regulations (Sale of Non-Prescription Preparations Not in Pharmacies or by Pharmacists) – 2004, Advertisements may not include sweepstakes or distribution of further preparations in exchange for purchases. Preparations may not be distributed as inducements to purchase other goods.

4.6 Is it possible to offer to provide, or to pay for, additional medical or technical services or equipment where this is contingent on the purchase of medicinal products? If so, what conditions would need to be observed? Though not specifically mentioned in the relevant rules, regulations and codes, it would seem inappropriate to condition material aid on the purchase of medicinal products, as this would be in breach of general codes of conduct.

4.7 Is it possible to offer a refund scheme if the product does not work? If so, what conditions would need to be observed? Does it make a difference whether the product is a prescription-only medicine, or an over-the-counter medicine? Pursuant to the Joint Ethical Convention, during the course of research, if the product does not work or damage is caused, a refund or damages may be paid.

4.8 May pharmaceutical companies sponsor continuing medical education? If so, what rules apply? There are no laws which specifically prohibit the sponsorship of continuing medical education (“CME”). In practice, sponsorship of CME, though subject to maintaining academic freedom, is quite common.

5 Hospitality and Related Payments

5.1 What rules govern the offering of hospitality to health professionals? Does it make a difference if the hospitality offered to those health professionals will take place in another country? Offering hospitality to health professionals should be examined in light of the Public Service Law (Gifts) – 1979 (see question 9.1) and the Penal Law (see question 4.1) may apply to extreme cases. Further, offering and receiving hospitality should be considered in light of the general conduct code of the Doctors Ordinance – 1976. According to the Joint Ethical Convention, subject to qualifications and restrictions, pharmaceutical companies and medical unions may sponsor conventions and conferences. The fact that the convention is sponsored must be clear and transparent. The Convention, inter alia, states that there should be no connection between the sponsoring body and the individual doctor/invitee, rather, the invitations must be sent to the invitee’s employer. Payment for participation in the convention is also provided to the employer rather than the individual attendee. A doctor may not attend a conference which is not significantly dedicated to medicine. The social programme and the hospitality must be modest and secondary in comparison to the purpose of the conference. Conventions may be held abroad. However, payment for such conventions by pharmaceutical companies, should be via research funds of professional unions or known medical institutions. It should be noted that pursuant to the Joint Ethical Convention, an Ethical Code Surveillance Committee was formed. The five member Committee, chaired by a retired judge, inter alia, may deliver Pre-Rulings on ethical questions raised by representatives of companies, privy to the Joint Ethical Convention. The Committee may deal with questions relating to sponsorship of scientific meetings. Pre-Rulings which authorise activities, will prevent hearing complaints relating to the authorised activities. Further, the Israel Medical Association set up a forum which regularly provides opinions on the relationship between pharmaceutical companies and doctors.

5.2 Is it possible to pay for a doctor in connection with attending a scientific meeting? If so, what may be paid for? Is it possible to pay for his expenses (travel, accommodation, enrolment fees)? Is it possible to pay him for his time? Pursuant to the Joint Ethical Convention, generally, though this matter should be examined on a case to case basis, subject to reasonability, doctors’ accommodation at scientific meetings may be paid for. However, it would seem that payment for the doctor’s time at a scientific meeting, would be in breach of the Convention.

5.3 To what extent will a pharmaceutical company be held responsible by the regulatory authorities for the contents of and the hospitality arrangements for scientific meetings, either meetings directly sponsored or organised by the company or independent meetings in respect of which a pharmaceutical company may provide sponsorship to individual doctors to attend? The majority of the pharmaceutical companies are privy to the Joint Ethical Convention and as such, are subject to its rules and regulations, which inter alia, relate to scientific meetings and sponsorships. Breach of the Convention, may result in a reprimand and/or cancellation of the right to use the ethics symbol (which indicates that a company is privy to the Convention) and/or a fine of approximately US$12,500. Decisions relating to infringements of the Ethical Convention are distributed among the Convention’s members. Additionally, decisions may be made public. It should be noted that the negative publicity may supersede the financial damage. Moreover, in extreme cases, Sections 290, 291 and 293 of the Israel Penal Law – 1977 (see question 4.1 above) may apply.

5.4 Is it possible to pay doctors to provide expert services (e.g. participating in focus groups)? If so, what restrictions apply? Pursuant to the Joint Ethical Convention, subject to the abovementioned restrictions and qualifications, reasonable payments and the return of expenses, such as travel fare, are acceptable in relation to lecturers and moderators.

5.5 Is it possible to pay doctors to take part in post marketing surveillance studies? What rules govern such studies? According to the Joint Ethical Convention, doctors may take part in research funded by a pharmaceutical company and receive payment for conducting the research, subject to qualifications and restrictions. Namely, doctors must maintain their independence during the research and payment cannot have any connection to the research’s outcome and results.

5.6 Is it possible to pay doctors to take part in market research involving promotional materials? The above must be examined in a case to case basis. Though it would seem that promotional materials cannot be disguised as “research”.

6 Advertising to the General Public

6.1 Is it possible to advertise non-prescription medicines to the general public? If so, what restrictions apply? It is allowed to advertise non-prescription medicines to the general public, subject to restrictions and qualifications. Pursuant to the Pharmacists Regulations (Preparations) – 1986, it is prohibited to advertise preparations in a manner which contradicts the information depicted in the Preparations Registry. Additionally, it is prohibited to advertise preparations in the media or nonscientific journals without authorisation by the General Director of the Ministry of Health (“Director”). The Pharmacists Regulations (Sale of Non-Prescription Preparations Not in Pharmacies or by Pharmacists) – 2004, outline the following relating to the advertisement of non-prescription preparations: Advertisements may not mislead, intimidate, cause tension or imply that use of the preparation will provide consumers with advantages which are not in accordance to the information depicted in the Preparations Registry. Advertisements may not encourage minors to use preparations. Advertisements must be clear and precise. The following warnings must be included: 1. “Before use it is advised to consult with a doctor or pharmacist and review the consumer’s pamphlet”. 2. “Contains active ingredient __________________”. Advertisements which include a photo of the preparation or its package do not require authorisation by the Director, provided the following appear: the preparation’s trade and generic names; its strength; manner of consumption; quantity; authorised purpose; and the appropriate warnings. Advertisements may not be targeted at youth aged sixteen (16) and under. Advertisements cannot be disseminated in military installations, prisons or schools. The Director may authorise such advertisements if he reasonably assumes that such advertisements may benefit the health of soldiers, inmates or pupils. Advertisements may not include sweepstakes or distribution of further preparations in exchange for purchases. Preparations may not be distributed as inducements to purchase other goods. Compared preparations within comparative advertisements must contain identical active ingredients and the Director must be convinced, based on scientific research, that one preparation is superior to the next. The Ministry of Health’s Procedure No. 24 sets further restrictions. According to Procedure No. 24, the following are prohibited: An announcement or statement which cannot be substantiated. Expressions such as “the best”, “the most efficient”, “the only”, “the solution”. Advertisements which encourage uneducated use of medicine. Advertisement which claim or imply that non-use of the drug will damage health or the drug is always affective and safe.

6.2 Is it possible to advertise prescription-only medicines to the general public? If so, what restrictions apply? Generally, pursuant to the Ministry of Health’s Procedure No. 24, it is prohibited to advertise, in any manner, prescription medicines. In exceptional circumstances in which it is important to disseminate explanatory information, the Ministry of Health may authorise such dissemination, which may be provided personally by the doctor to the patient. Such material may not be distributed in pharmacies, clinics, doctors’ waiting rooms, etc. The Second Television and Radio Authority Rules (Television Advertising Ethics) – 1994, prohibit advertising prescription-only medical preparations on private television. Similar rules, relating to cable and satellite, appear in Communication Rules (Bezek and Broadcasting) (Advertisements, Services and Sponsorship Broadcasting on designated Channels) – 2004. Recently, some of the pharmaceutical companies have been advertising prescription medicines without specifically mentioning the medicines’ brands. In lieu of mentioning the medicines’ brands, advertisers will use letters and/or colours associated with the medicine. Occasionally, during the advertisements, advertisers will provide a phone number “for additional information”. Though controversial, as of yet, the courts were not forced to render a ruling on the matter.

6.3 If it is not possible to advertise prescription only medicines to the general public, are disease awareness campaigns permitted, encouraging those with a particular medical condition to consult their doctor, but mentioning no medicines? What restrictions apply? As mentioned above, pursuant to Announcement No. 24, subject to advance authorisation by the Ministry of Health, in exceptional circumstances, in which it is extremely important to disseminate explanatory information, such as disease awareness, explanatory information (not advertisements) may be provided.

6.4 Is it possible to issue press releases concerning prescription only medicines to non-scientific journals? If so, what conditions apply? Subject to the above-mentioned rules and qualifications, press releases are allowed provided they are not disguised advertisements.

6.5 What restrictions apply to describing products and research initiatives as background information in corporate brochures/Annual Reports? Product description and research may be published in brochures and annual reports, provided the material does not contradict the information depicted in the Preparations Registry.

6.6 What, if any, rules apply to meetings with and funding of patient support groups, including any transparency requirement as regards the recording of donations and other support in corporate reports? All publications must be transparent and sponsors must be revealed.

7 The Internet

7.1 How is Internet advertising regulated? What rules apply? How successfully has this been controlled? Unlike The Second Television and Radio Authority Rules (Television Advertising Ethics) – 1994, which apply solely and specifically to television advertising, there are no specific laws relating solely to Internet Advertising. However, laws, such as the CPL, define general rules applicable to all types of media, inclusive of Internet.

7.2 What, if any, level of website security is required to ensure that members of the general public do not have access to sites intended for health professionals? The Privacy Law – 1981 defines the rules and regulations relating to data bases, their registration, administration and management. Breach of the Privacy Law may result in a prison term of five (5) years.

8 General – Medical Devices

8.1 What laws and codes of practice govern the advertising of medical devices in your country? There are no laws which specifically govern the advertising of medical devices. Promotion of medical devices would be subject to general consumer protection laws and regulations, such as the CPL.

8.2 Are there any restrictions on payments or hospitality offered to doctors in connection with the promotion of a medical device? Again, there are no specific laws on medical devices. However, the general laws, codes and regulations, relating to ethical practices, behaviour and standards, in certain circumstances, may be interpreted to apply to medical devices.

9 Developments in Pharmaceutical Advertising

9.1 What have been the significant developments in relation to the rules relating to pharmaceutical advertising in the last year? While the Joint Ethical Convention extensively governs the relationship between doctors and pharmaceutical companies, there is only limited primary legislation on this topic. Thus, the current legal situation is unclear and many questions remain unsettled. In 2006 the Israeli legislature, the Knesset, enacted the National Economy Regulation Law (Legislation Amendments for Achieving the Budget Objectives and Economic Policies of the 2006 Fiscal year) – 2006 (“Regulation Law”). Inter alia, the Regulation law has amended the Public Service Law (Gifts) – 1979, in a manner that redefines “public servants”. Following the amendment, a “public servant” includes employees of public hospitals and healthcare service organisations. Pursuant to the Public Service Law (Gifts), subject to qualifications, public servants may not receive gifts which exceed a modest value and are not customary. It has yet to be seen if the amendments, which came into effect on September 1, 2006, will affect the relationships between hospital employees, healthcare service employees and the pharmaceutical manufacturers, importers and distributors or whether, current practices will be considered legal in accordance to the law’s qualifications. As of yet, the courts have not rendered a ruling on the subject. 9.2 Are any significant developments in the field of pharmaceutical advertising expected in the next year? The Ministry of Health is currently in the process of drafting a Bill directed at the marketing and advertising of prescription only medicines. The Bill, inter alia, will prohibit any type of advertising, either direct or indirect, such as use of colours, letters, logos and hints of the drug’s purpose without actually mentioning the drug. Thus, advertisements which market a prescription drug without actually mentioning the drug’s name/brand, will be outlawed.

9.3 Are there any general practice or enforcement trends that have become apparent in this jurisdiction over the last year or so? As mentioned in question 6.2, generally, it is prohibited to advertise, in any manner, prescription medicines. Though in exceptional circumstances, the Ministry of Health may authorise the dissemination of informative material which is of extreme importance to the public. Accordingly, within the last year, the Ministry of Health authorised the distribution of explanatory leaflets relating to contraceptives. However, since the leaflets were not provided directly from doctors to patients, as prescribed in Procedure No. 24, rather simply made available in doctors’ waiting rooms, the Ministry of Health no longer authorises their distribution.

David Wolberg

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