Contributed By Law Office of Gheidi & Associates
There are some laws and bylaws that regulate advertising on medicines in Iranian jurisdiction suggesting a general framework for the issue and not prescribing all necessary legal ingredients. These laws and bylaws are as follows: ¬
No self-regulatory codes apply. However the Disciplinary Prosecution Office as a self-regulatory authority is a specifically authorised judge over healthcare professionals’ violations, The abovementioned office has no jurisdiction over pharmaceutical companies’ violations, as to which public courts have the competency to judge.
The Instruction of the Advertisement of Medicinal, Food, Beverage, Cosmetic, Health and Medical Products and Affairs defines advertising as follows:
“The publication of any notification through public and private media including but not limited to radio, television, satellite television channels, press, cinema, intranet, corporate networks, video and journals for introduction of materials, goods and services.”
Under this definition any publication for introducing a product by any means for marketing purposes is considered as advertising.
Although no clear distinction has been suggested between information and advertising under the rules, the legislator seems to have drawn a subtle line between these two. For instance, while the advertising of pharmaceutical products is prohibited in public media, there is no restriction of broadcasting the new scientific findings on public media provided that they do not involve advertising. So as long as disease awareness campaigns are not held for marketing purposes to develop the sale of a product, they are not regarded as an advertisement.
Based on the Executive Bylaw of Advertisement and Presenting Scientific Information of Pharmaceuticals and Biological Materials, press releases regarding medicines are allowed in Iran, to which, however, several restrictions apply. Firstly, only healthcare professionals shall be allowed to receive those publications and they shall not be made available for the public. Secondly, only press releases which are categorised as medical science journals are allowed to contain information of pharmaceutical products. So other press releases such as social, political and economic are prohibited to advertise medicines.
As a general rule, companies are only permitted to introduce and provide information about their own medications and are not permitted to compare their product with other companies’ products. Devaluing other products is strictly prohibited.
With regards to advertising, it shall be noted that only authorised products are allowed to be advertised. In fact, companies are allowed to advertise products which are already approved by the Food and Drug Administration Office. For instance, the marketing of narcotics is strongly prohibited. But with regards to providing information, there are no specific provisions or guidelines regulating unregistered products or indications in this respect. Therefore, it can be concluded that there is no restriction to provide information on unauthorised medicines or unauthorised indications.
There is no restriction to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals.
It should also be noted that any scientific conference must follow a certain procedure to be approved by the relevant authority. Hence, depending on the target audience, the subject matter of the conference may be a ground for rejection.
As long as such information is sent to healthcare professionals for non-marketing purposes, they are not considered advertising and therefore no restrictions apply for such a transfer of information. Scientific information must be logical and always be accompanied with evidence-based scientific documentation.
There are no specific provisions or guidelines in this respect. However, it must be noted that producers and importers are only allowed to import and produce products which are already approved and licensed by the Food and Drug Administration Office.
Pursuant to the Executive Bylaw of Advertisement and Presenting Scientific Information of Pharmaceuticals and Biological Materials, the direct advertisement of medicines to the public by any means such as public media is prohibited. Also, based on the Instruction of the Advertisement of Medicinal, Food, Beverage, Cosmetic, Health and Medical Products and Affairs advertising of medicines and their therapeutic effects is prohibited in public media. Furthermore the introduction of the medicines in newspapers, weeklies, magazines and other social journals, such as political and economic ones, even if they exclusively are distributed to healthcare community is not permitted. As a result, advertising directed at the general public is prohibited in Iran.
It is worth mentioning that according to the former Executive Bylaw of Advertisement and Presenting Scientific Information of Pharmaceuticals and Biological Materials, which is not in effect any longer, brochures intended for healthcare professionals that were provided for introducing and presenting prescription-only medicines and over-the-counter medicines must include specific information such as therapeutic effects of the medicine, indications, warnings and side effects.
However, under the subsequent Executive Bylaw of Advertisement and Presenting Scientific Information of Pharmaceuticals and Biological Materials, the abovementioned requirements have been eliminated. Currently, there is no requirement applying to the advertising of prescription-only medicines and over-the-counter medicines.
As mentioned earlier, pharmaceutical advertisement to the general public is strongly prohibited. Only publishing new scientific findings of the medicines in public media without mentioning of the specific medicines’ names or manufacturer institutions and with permission of the Food and Drug Administration is allowed.
There are no regulations or self-regulatory codes for restriction on interactions between patients or patient organisations and industry.
There is no restriction on endorsements by healthcare professionals in advertising for medicines. We are told that, in practice, pharmaceutical companies use healthcare professionals’ confirmation and endorsement to improve their medicines authenticity for the purpose of marketing.
Under general advertising rules, advertisements must not devalue other goods and services and must not outrage public decency, advertisements must avoid promoting corruption and opposing official religions; and false advertising and misrepresentation which mislead or confuse consumers is prohibited. Under specific rules, designating a commission or bonus to encourage healthcare professionals to buy or prescribe medications is prohibited.
Pharmaceutical advertisements shall be based on logical and scientific facts. Furthermore, provided information about the drugs should be transparent and complete and must always be accompanied with evidence-based scientific documentation. If a drug’s licence has provided certain requirements be met before prescription or use of the drug, such requirements shall be mentioned in the advertisement as well.¬
Using proprietary names and generic names are allowed to be used in advertisements. Advertisements must also contain full details of the manufacturer or importer of pharmaceutical products including name, address, telephone and email address.¬
Mentioning the given permissions from an official authority regarding drugs is permitted. However promotional use of the logo of the Ministry of Health and Medical Education, or Food and Drug Administration is prohibited.
As long as the advertised products are approved and licensed by the Food and Drug Administration Office and the provided information is based on scientific facts, there is no restriction.
Companies are allowed to provide healthcare professionals with reprints of journal articles.
Advertisements of medicines are exclusively allowed by pharmaceutical companies which have obtained the activity certificate issued by the Ministry of Health and Medical Council. Moreover they shall have obtained the manufacturing licence or importing licence from the Food and Drug Administration Office.
Moreover, only drugs listed in “Iran’s Drug List” are allowed to be advertised. The list can be found at: www.fda.gov.ir/item/463.
Any advertisement within the pharmaceutical and healthcare services without the written approval of the relevant authority is prohibited based on the Disciplinary Proceedings of Healthcare Professional Bylaw.
There are no legal requirements for companies to have specific standard operating procedures (SOPs) in relation to advertising. Nevertheless, pharmaceutical institutions could voluntarily arrange and adopt SOPs in accordance with their standards and procedures.
Pursuant to the Executive Bylaw of Advertisement and Presenting Scientific Information of Pharmaceuticals and Biological Materials, pharmaceutical institutions are allowed to employ or engage natural and legal persons holding the related licence by the Food and Drug Administration as the scientific representatives to advertise their products. Therefore, their activities should comply with the norms of professional ethics, religious, legal, scientific and conditions of the bylaw. Pharmaceutical institutions take the responsibility of such representatives engaged by them. In practice, the scientific representatives shall have the licentiate or higher degrees in the medical, health or biology fields.
Based on the Executive Bylaw of Advertisement and Presenting Scientific Information of Pharmaceuticals and Biological Materials,the advertising of medicines is only allowed on specialised medical scientific websites designed exclusively for healthcare professionals.
There are no regulations concerning advertising on social media specifically. However, as mentioned above, these advertisements must only be directed to healthcare professionals. Access by the public shall be restricted.
All companies are required to include access restrictions on websites containing advertising or other information. These websites shall be only accessible by healthcare professionals.
Based on the Executive Bylaw of Advertisement and Presenting Scientific Information of Pharmaceuticals and Biological Materials,in case of any proposal inconsistent with professional ethical principles from pharmaceutical institutes, healthcare professionals are required to report to the Food and Drug Administration Office in writing. They should disclose a pharmaceutical institution’s name and specification of proposal. Failure to report the case should be considered as a violation of law by the healthcare professionals and may be pursued by the Food and Drug Administration.
Under the same condition, if pharmaceutical institutions receive any request contrary to the professional ethics or provisions of this regulation from healthcare professionals that leads to the unreasonable prescription or recommendation of drugs, they are required to report to the Food and Drug Administration office in writing. Failure to report the case should be considered as a violation of law by pharmaceutical institutions and may be pursued by the Food and Drug Administration.
Offering any financial or non-financial assistance, support, consultancy and benefits or the like for prescription, recommendation, purchase and consumption of pharmaceutical products is prohibited. Promotional gifts that are donated by pharmaceutical institutions or healthcare professionals should not contain any material value.
Pursuant to the Executive Bylaw of Advertisement and Presenting Scientific Information of Pharmaceuticals and Biological Materials, gifts donated by pharmaceutical companies to healthcare professionals for advertising purposes must be related to healthcare affairs and also be used for the benefit of patients. They should include features of the drug and information of the institution. In addition, they are not supposed to be salable nor unjustifiably encouraging to prescribe medicines. As a primary limitation, it is important to take into account that the gifts must have no material values.
Pharmaceutical companies are allowed to provide some samples to healthcare professionals provided that the following phrase, in red and an appropriate font, has been written on the sample: “free drug sample and unsalable."
Healthcare professionals are prohibited to sell these samples by any means. However, they are allowed to prescribe these samples to patients for free. In addition, providing healthcare professionals with free samples of narcotics or controlled drugs or medicines is prohibited. However, pharmaceutical companies are permitted to provide a packaging maquette of these kinds of drugs to healthcare professionals.
It should also be noted that dossiers relating to the given samples should be properly recorded by pharmaceutical companies and be accessible by authorities.
In order to enhance medical knowledge, pharmaceutical companies can sponsor scientific conferences and relevant seminars by donating to them scientific and financial help, provided that financial aids are paid directly to the official account of the organiser of the conference which can be scientific institutions or Medical Sciences universities. These pharmaceutical companies must make sure that organisers include names of sponsors and assistants in the relevant brochures. In addition, they are obliged to maintain all related documents for at least five years so that it can be submitted, upon request, to the competent authorities.
There is no difference and separation between international and national congresses in the bylaws, and the provisions apply to both domestic and foreign conferences.
Companies are only permitted to organise or sponsor events with the purpose of promoting scientific level. Companies are only allowed to undertake medical students and healthcare professionals’ travel costs, conference registration fees and accommodation costs. The subject matter of the conference must be related to the specialty of the student or healthcare professional.
All costs incurred by the pharmaceutical companies shall be clearly stated in the invitation letters. Holding hospitality events by pharmaceutical companies is acceptable if they are listed before the conference program.
The companies are responsible for declaring any costs beyond the abovementioned to the Food and Drug Administration Office in writing immediately.
Legislators have not explicitly stipulated regulations for providing grants or donations to healthcare professionals. In fact, no difference has been drawn between gifts and grants or donations in the regulations. However, gifts for advertising purposes should have no material value.
Although it is forbidden to advertise the drugs by determining the award, prize or commission to encourage an addressee to prescribe or purchase the drugs, pharmaceutical companies are explicitly allowed to sell their products to pharmacies at a lower price than the price set by the Food and Drug Administration Office. However, they must still obtain prior permission from the Food and Drug Administration Office.
There are neither explicit provisions on paying for services provided by healthcare professionals (during congress) nor special provisions prohibiting suppliers and manufacturers of medicinal products from employing healthcare professionals for the purposes of providing expert services.
Giving discounts to pharmacies by pharmaceutical companies requires the prior permission of the Food and Drug Administration Office. Moreover, companies are responsible for declaring any costs beyond those that are mentioned previously in this section to the Food and Drug Administration Office in writing immediately.
Companies are not obliged to disclose the details of transfers of value to healthcare professionals or healthcare institutions in Iran. The only legal requirement is to provide the tax declaration that may contain such a transfer of value to the tax administration per year.
As mentioned earlier, there is no obligation on companies to disclose the details of transfers of value to healthcare professionals or healthcare institutions in Iran. However, the legal requirement on tax declarations as explained above apply to both Iranian companies and foreign companies who have established an entity in Iran.
In order to find competent enforcement bodies, we need to draw a distinction between pharmaceutical bodies and healthcare professionals.
As a general rule, the responsible bodies to enforce the rules on advertising are public courts. However, according to Articles 28 & 29 of the Medical Council Establishment Law and Article 41 of the Disciplinary Proceedings of Healthcare Professional Bylaw, a healthcare professionals’ violation of law must be referred to the Disciplinary Prosecution Office as a self-regulatory authority.This prosecution office is specifically designed for healthcare professionals’ violations. It must be noted that this office has no jurisdiction over pharmaceutical companies and the disputes against these companies must be referred to competent public courts.
According to Article 7 of the Consumer Protection Law and its relevant executive bylaws, false advertising and misrepresentation which misleads or confuses consumers is prohibited, over which the Governmental Discretionary Office is responsible for enforcement.
Furthermore, in case the violation of these provisions amount to a criminal offence, then the criminal courts are competent to judge.
Disputes against healthcare professionals can be reported to the Medical Council or Disciplinary Prosecution Office directly and disputes against pharmaceutical companies shall be referred to a public court.
Moreover, violations of anti-competitive practice can be reported to the Competitiveness Council, which has the competency to judge and impose penalties against a violating party.
Pursuant to Article 28 of the Medical Council Establishment Law and Article 37 of the Disciplinary Proceedings of Healthcare Professional Bylaw, the Disciplinary Prosecution Office can either give oral or written warning and admonition, or suspend the licence for up to one year. Generally, as to pharmaceutical companies, financial penalties may be imposed.
There is no particular process adopted by the self-regulatory authority in this regard.
There is no special recent enforcement trends in relation to pharmaceutical advertising in our jurisdiction.
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