Advertising and promotionRegulation
Summarise the rules relating to advertising and promotion of medicinal products and medical devices, explaining when the provision of information will be treated as promotional. Do special rules apply to online advertising?
The Pharmacists Regulations – Preparations and the Pharmacists Regulations – Sale of Preparations Without a Prescription, Outside a Pharmacy, and Not by a Pharmacist (2004) (the 2004 Regulations) are the laws that specifically regulate pharmaceutical advertising in Israel. The general Consumer Protection Law (1981) and its related regulations are also relevant.
There are also several Ministry of Health (MOH) 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 – Commercial Engagements by Medical Institutions.
There are also advertising rules enacted by the National Second Authority for Television and Radio.
Finally, the 2014 Joint Code of Ethics between the Israeli Medical Association and the Representative Organisations of the Pharmaceutical Companies Active in Israel (the Joint Ethics Code) regulates pharmaceutical advertising. The main representative organisation party to the Joint Ethics Code is Pharma Israel.
In section 1 of the Pharmacists Regulations – Preparations, advertising is defined as ‘providing information in writing, through the media or by any other means’. In section 1 of the 2004 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’. These general definitions of advertisement apply to all potential forms of advertisement. The definition is general and applies to all target audiences. However, disease awareness campaigns and other information can be provided to patients and doctors.
The MOH regulates the advertisement of devices and, if an advertisement causes harm (or has the potential to harm) to the public, the MOH can order the registration holder to stop selling the device, condition sale on compliance with conditions or limit the type and form of advertisement set by the MOH under section 12 of the Medical Device Law. The MOH uses this standard, although further regulations need to be enacted for the Medical Device Law to come into force. The Israeli Consumer Protection Law also prohibits misleading advertisements.
The Physicians Ethics Code prohibits doctors from advertising in a manner that causes undue pressure on patients in clinics. Healthcare professionals that work at medical government institutions (which comprise most medical institutions), governmental clinics, and private entities that act under an MOH licence and their employees are restricted in their ability to have promotional material in their offices unless pre-authorised (MOH Rule 13-2018).
Finally, the MOH has limited pharmacists’ ability to engage in the promotion of drugs and medical devices.Inducement
What regulations exist to discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medicinal product or medical device?
Healthcare professionals that work at medical institutions cannot accept any gifts under MOH Rule 13-2018, section 14.6. According to section 50 of the Joint Ethics Code, doctors can accept nominal gifts.Reporting transfers of value
What requirements apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices?
There is a disclosure requirement for foreign and domestic companies. If the yearly total provided by the company is greater than 2,500 shekels, the company must report donations to the MOH once annually under the provisions of section 40a of the National Insurance Law.Enforcers
Describe the bodies involved in monitoring and ensuring compliance with advertising controls for medicinal products and medical devices, distinguishing between any self-regulatory framework and control by the authorities.
The MOH can act to order the advertisement’s removal and order the publication of a clarification. Actions that can lead to fines or imprisonment can be initiated by the MOH under section 5.8 of MOH Rule 04/24.
There are also enforcement capabilities under the Joint Ethics Code that create a joint enforcement forum by combining members of industry and doctors.Sanctions
What are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?
Courts can impose sanctions of up to 150,000 shekels for a violation of the rules on advertisements by an individual and 300,000 shekels for a violation by a company. Under a temporary article of the Pharmacists Ordinance, violators of the Pharmacists Regulations – Sale of Preparations Without a Prescription, Outside a Pharmacy, and Not by a Pharmacist are subject to up to six months in prison.
The potential sanctions for violations of an order related to the advertisement of a medical device are one year of imprisonment. Fines can be as high as 226,000 shekels and are doubled for corporations. Similar sanctions are possible under consumer protection law.
Inducements can be handled under anti-bribery legislation. The punishment for bribing a public official is up to seven years of imprisonment, a fine of up to 1 million shekels for individuals, a fine of up to 2.2 million shekels for companies or four times the amount of the bribe, or a combination thereof. Gifts in an amount greater than a nominal value given to healthcare professionals also can violate the Civil Service (Gifts) Law (1979). This law allows for civil servants to be fined an amount of up to three times the value of the gift.
Sale and supplyRegulation
Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?
The list of controlled substances can be found in the Controlled Substances Ordinance (1973). The special rules governing the dispensing or sale of such products are regulated under Ministry of Health (MOH) Rule 08/2018.Online supply
What laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?
Pharmacies can allow patients with prescriptions to order online in accordance with MOH Guideline 128. Promotion and advertisement of prescription drugs are prohibited in Israel. However, the price of the medicine and a link to its patient leaflet on the MOH website can be shown on the pharmacy’s website.Pricing and reimbursement
What are the controls imposed on pricing of medicines and medical devices and reimbursement by national social security systems that are applicable to manufacturers, distributors and pharmacists?
New drugs and devices are approved and added to the national medical basket based on recommendations by a public committee on an annual basis. The additional budget for new drugs and devices is usually approved in advance and the committee decides which drugs or devices to recommend for inclusion. The basket relates to drugs and devices that the sick funds, under Israeli nationalised medicine, must provide to their members. The cost of drugs is negotiated by the Ministry of Health and, at times, by the sick funds. The committee’s recommendations regarding new drugs and devices are based on the cost of the treatment and other factors.
The maximum price of branded drugs without a generic competitor is determined by the average of the three lowest costs in Belgium, Hungary, France, the United Kingdom, Germany and the Netherlands. The price of a branded drug with a generic competitor or a generic drug is under the supervision of a governmental committee and a petition needs to be filed to have the price raised. This is provided for in the Supervision of Prices of Goods and Services Law 1996, the Order Supervising Prices and Goods (Maximum Price of Prescription Medicines) 2001, and the Order Supervising Prices and Goods (Implementing the Law on Medicines) 2001.
There are four sick funds in Israel. Israeli citizens must join one of the funds, which provide healthcare under the Israeli national healthcare system.