Advertising of medicines in Argentina is regulated by a combination of laws and regulations issued by the National Ministry of Health and the National Administration of Medicines, Food and Medical Technology (ANMAT), jointly with a code of conduct adopted by the pharmaceutical industry. The ANMAT is the national enforcement authority in charge of regulating and controlling medicines and medicinal products, including advertising of medicines.
Law No 16,463 (the “Medicines Act”) and its Regulatory Decree No 9763/1964 regulate the most relevant activities in the pharmaceutical industry, including advertising of medicines.
ANMAT Disposition No 4980/2005 regulates the advertising of over-the-counter medicines, as does the National Ministry of Health’s Resolution No 20/2005 which states that any advertising regarding over-the-counter medicines must observe the ANMAT’s criteria.
The National Ministry of Health’s Resolution No 627/2007 regulates the promotion of prescription-only medicines. Additionally, the National Ministry of Health’s Resolution No 6516/2015 regulates the obligation of pharmaceutical companies to notify the ANMAT of the advertising they intend to introduce to HCPs, as discussed further in 6.1 Requirements for Prior Notification/Authorisation.
Also, the ANMAT’s Disposition No 2845/2011 introduces the “Programme for Monitoring and Control of Advertising and Promotion of Products Subject to Health Surveillance”, whose objectives are described in 11.2 Initiating Proceedings for Pharmaceutical Advertising Infringements.
In addition, Law No 24,240 (the “Consumer Protection Act”) as well as National Decree 274/2019 (the “Fair Trading Decree”) and the National Civil and Commercial Code provide general mandatory guidelines for advertising any types of products and services, including medicines.
Finally, Argentine provinces and the Autonomous City of Buenos Aires are competent for the issuance of rules on advertising of medicines. In this respect, some of the most relevant local regulations are:
In general, the provincial laws are aligned with national laws and regulations.
Code of Ethics
The Argentine Chamber of Medicinal Specialties (CAEMe), which represents most foreign pharmaceutical and biotechnology companies that develop and commercialise medicines in Argentina, has adopted a code of ethics which sets forth certain standards for the promotion of pharmaceutical products and interactions with healthcare professionals (HCPs), healthcare organisations (HCOs) and patient organisations (POs).
In Argentina, CAEMe’s self-regulated code of ethics is applicable to all pharmaceutical companies that are members of CAEMe. The code of ethics sets forth standards for:
CAEMe’s members must comply with the ethical standards set forth in this code, and are therefore responsible for both their non-compliance and for third parties’ non-compliance (ie, those who enter into contracts or any type of agreement with CAEMe’s members).
The Medicines Act and its related regulations consider advertising as any form of announcement to the general public, including through all forms of media, whether traditional media such as television, radio and ads in public roads, or others such as the internet and so-called non-traditional advertising (NTA).
The ANMAT defines pharmaceutical advertising or propaganda as a technique applied in an organised manner through the media to inform or promote features, benefits or qualities of medicines to encourage their sale.
CAEMe’s self-regulating code of ethics understands pharmaceutical advertising as being any action carried out, organised or sponsored by a member company, directly or indirectly through a third party, aimed exclusively at HCPs for the purpose of promoting the prescription, recommendation, acquisition, distribution, dispensing, administration or consumption of its medicines through any means of communication.
Therefore, advertising is considered as any:
Information refers to a product’s technical characteristics which the regulations require to be included explicitly in all medicines’ labels, prospectuses and advertisements. Thus, in contrast to advertising, information refers specifically to medicines’ particularities that the patients must be aware of in order to be fully informed before purchasing and consuming the medicines (eg, technical information, dosage, adverse effects), which excludes any other type of promotion of the medicines’ features, benefits or qualities to encourage their sale.
It should also be noted that, according to CAEMe’s code of ethics, the following activities will not be considered advertising of medicines:
Disease awareness campaigns are allowed in Argentina, but they are considered advertising if they mention the pharmaceutical company’s name, or any other information related to it, including websites, address or any contact information. However, it should be noted that if the campaign is made by a pharmaceutical company that markets or manufactures over-the-counter medicines, it will be considered as advertising permitted by the legal framework.
Press releases on prescription-only medicines are prohibited when they are accessible to the general public. However, publications in magazines, newsletters, books, or audio-visual media directed exclusively towards HCPs authorised to prescribe or dispense medicines are allowed.
The Argentine Supreme Court of Justice has considered irregular the publication of an article in a newspaper of massive diffusion that promoted a prescription medicine. It was considered that, notwithstanding the fact the advertisement was addressed to the HCPs, the general public had access to it and, therefore, it breached the rules on advertising of medicines.
According to CAEMe’s code of ethics, the following shall not be considered promotional activity, provided there is no relationship between the member company or brand/medicine owner and the company responsible for the edition or the author of the information: texts written and prepared by journalists in the course of their professional work in regular editions, supplements, special issues or editions, or others, of newspapers, magazines, television or radio programmes, etc, in which information about drug therapies, specific treatments, medicines submitted as novelties, scientific studies, papers, references to a medicine, lines of research, product launches, press conferences, publications, etc is presented as a news item, an interview, a debate, an editorial or another similar format.
In Argentina, comparative advertising is a commercial announcement that explicitly or implicitly alludes to a competitor, its brand or the products offered by it. The comparison will be acceptable as long as it follows the guidelines set forth by the Fair Trading Decree – ie, as follows:
In particular, based on the Fair Trading Decree, the comparative advertisement for the medicine should not:
Under Argentine regulations, advertising of unauthorised medicines or indications is not allowed.
In this respect, CAEMe’s self-regulating code of ethics provides that medicines should not be promoted in the country until the relevant authority grants the medicine a marketing authorisation.
However, CAEMe’s code of ethics sets forth that the activities listed in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information shall not be considered prohibited promotion of unauthorised medicines or indications.
In accordance with CAEMe’s code of ethics, information distributed to HCPs participating at national or international scientific conferences may refer to unauthorised medicines or indications, as long as it is not promotional in nature.
In the case of international conferences in particular, CAEMe’s code of ethics sets forth that the following rules must be met:
As mentioned in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, CAEMe’s code of ethics:
In this respect, the code of ethics expressly states that the prohibition described in the first item above does not intend to impede the right of the scientific community and the public to be fully informed about scientific and medical progress. Also, it does not intend to restrict a full and proper exchange of scientific information concerning a pharmaceutical product, including appropriate dissemination in the scientific or general media and at scientific conferences of research findings.
The code of ethics provides that it is proper and permissible to debate on and expose the scientific sphere regarding the breakthrough of new medicines, even where they are not yet approved by the health authorities.
In Argentina, the CAEMe’s code of ethics stipulates that sending information on unauthorised medicines or indications to HCOs so that they can prepare budgets is allowed, as long as the pharmaceutical companies do not induce or provide promotional statements. Therefore, they must expressly demonstrate that their intention is not to promote or advertise the product, but to provide information in order to help prepare budgets.
The ANMAT has in place an exceptional regime for patients to obtain medicines that have not been yet authorised in Argentina. Hence, it is permitted to publish the availability of such programmes as long as all the provisions set forth by the ANMAT’s Disposition No 4616/2019 are complied with.
In summary, the Disposition provides for specific situations where the early access exception may be requested, and for all the documents that the applicant must present. For advertising of medicines, the Disposition expressly prohibits the commercialisation or promotion of medicines brought into the country under the exceptional regime, on penalty of initiating the corresponding administrative and/or penal actions.
The Medicines Act stipulates that the only medicines that can be advertised to the general public are over-the-counter medicines, whose requirements are further described in 4.2 Information Contained in Pharmaceutical Advertising to the General Public.
The Medicines Act expressly forbids the promotion or advertising of prescription-only medicines to the general public, in any form. Promotion of prescription-only medicines is only allowed when directed exclusively to HCPs.
Only advertising for over-the-counter medicines can be directed to the general public. ANMAT Disposition 4980/2005 provides that the following information must be included:
Conversely, the following information is prohibited:
CAEMe’s code of ethics allows member companies to interact with patients, patient experts, patient advocates and caregivers, observing the following guidelines:
Conversely, CAEMe’s member companies may interact with POs in the following cases:
CAEMe’s code of ethics also presents a “Patient Support Programme” which refers to any programme organised by a member company aimed at assisting patients who have already been prescribed medication by an HCP and/or caregivers in the management of their disease with the appropriate use of medication, among other topics of interest related to the patient’s health.
The code of ethics also presents a “Diagnostic Support Programme” which refers to the support that member companies can provide for necessary diagnostic tests for patients, prior to a medicine prescription.
However, companies cannot use these programmes in order to promote their medicines (including prescription-only medicines) or unauthorised products.
The National Ministry of Health’s Resolution No 627/2007 dictates that advertisements directed at HCPs must provide the technical-scientific information necessary to make them aware of the medicine’s therapeutic properties, and in order to do so, must at least include the following.
The fact that the regulation foresees what minimum information advertisements must include implies that any other information (which must be certain, objective and verifiable) concerning the product may be submitted to HCPs.
In respect of prohibitions, the aforementioned Resolution sets forth that advertisements directed towards HCPs are forbidden for medicines that have not been authorised by the enforcement authority with the corresponding marketing authorisation.
The National Ministry of Health’s Resolution No 627/2007 expressly states that any promotional literature related to a medicine that is disseminated to HCPs should include at least the information referred to in 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals, so any reference to data not included in the summary of product characteristics may be delivered to HCPs as long as it is certain, objective and verifiable.
In this respect, CAEMe’s code of ethics dictates that the advertising may refer to data or other clinical studies that are not included in the summary of product characteristics, as long as it respects the meaning and objectives of the original file, and cites its sources.
Additionally, when the promotional material refers to published studies, these must be faithfully reproduced or provide a clear reference to them, to be able to know how to find them. Faithful reproduction should be understood as an accurate reflection of the meaning and content of the original source, without adding or excluding any information that could mislead or confuse the recipient.
Advertising the use of a medicine in combination with a medical device is permitted as long as the advertising materials are consistent with the summary of product characteristics of both products. In this respect, ANMAT Disposition No 7446/2019 stipulates that a combined product means any product consisting of two or more components, which when combined constitute a single entity. In this Disposition, the ANMAT provides a guideline for the procedure for obtaining the combination product’s approval and authorisation.
As regards advertisements, the rules described in 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals are applicable.
Companies may provide reprints of journal articles to HCPs, since they are considered an advertisement media; however, the reprints must observe the directions described in 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals, which should be made exclusively in publications or events for scientific dissemination only for professionals authorised to prescribe or dispense medicines; see 5.2 Reference to Data Not Included in the Summary of Product Characteristics.
The National Ministry of Health’s Resolution 627/2007 stipulates that quotes, tables and other illustrations taken from medical journals or scientific works that may be used in promotional literature should respect the meaning and objectives of these, and cite their sources.
Likewise, CAMe’s code of ethics provides that quotations taken from medical and scientific literature or personal communications should accurately reflect the author’s opinion and, where appropriate, should mention the product on which the author based their opinion.
To date, there are no relevant regulations in Argentina regarding medical science liaisons.
Advertising for medicines is not subject to prior authorisation from the regulator.
For over-the-counter medicines directed to the general public, ANMAT Disposition No 9660/2016 sets forth that it is not necessary to submit the advertising materials for the ANMAT’s control. The requirements for promoting over-the-counter medicines are described in 4.2 Information Contained in Pharmaceutical Advertising to the General Public.
Regarding prescription-only medicines, ANMAT Disposition No 6516/2015 provides that companies who intend to promote prescription-only medicines to HCPs must notify the ANMAT of such advertising, together with the corresponding promotional piece. The advertising requirements are described in 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals. This notification to the ANMAT must be made within 48 hours from the beginning of the materials’ dissemination, in the form of a sworn statement.
The Ministry of Health’s Resolution No 267/2007 on “Good Advertising Practices of Prescription-only Medicines” stipulates that pharmaceutical companies are responsible for establishing appropriate procedures for the training of medical advertising agents and/or medical visitors with sufficient scientific knowledge to present the information of the company, in order to provide the HCPs with all the information regarding the therapeutic benefits, adverse effects, contraindications, interactions, other therapeutic benefits and risks derived from the use of prescription-only medicines.
Likewise, CAEMe’s code of ethics dictates that member companies must ensure internal structures and procedures (including appropriate employee training) in order to ensure that promotional activities are conducted in a responsible and ethical manner.
Advertising medicinal products on the internet is subject to the same requirements imposed on traditional channels.
In this sense, when prescription-only medicines are advertised on the internet, companies must do so through a specific website, to which the general public has no access, since, as previously mentioned, their promotion must be exclusively directed towards HCPs.
In this respect, the ANMAT, through Disposition 4980/2005, clarifies that the internet may not be used as a mechanism for the direct sale of any types of medicines. All medicines (over-the-counter or prescription-only) may only be dispensed through pharmacies. It also suggests that the population refrain from acquiring and consuming any type of drug of unknown origin and that is not sold through legitimate channels of commercialisation (ie, pharmacies). This includes those offered through web pages and email messages as well as those promoted through classified advertisements.
Additionally, CAEMe’s code of ethics states that companies should have internal structures and procedures (including adequate training of employees) and ensure these activities are performed in a responsible and ethical manner, and in strict compliance with the regulations.
See 7.1 Regulation of Advertising of Medicinal Products on the Internet.
Companies are allowed to provide disease awareness information to patients online, as long as they observe the provisions described in 4.3 Restrictions on Interactions Between Patients or Patient Organisations and Industry and 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information.
Even though Argentina has no special regulation on online scientific meetings, CAEMe’s code of ethics stipulates that any type of similar scientific, promotional and/or educational activity should be understood as a scientific meeting.
Therefore, member companies may organise, sponsor or support scientific, educational or professional training events for the different actors of the healthcare system, in order to improve their level of knowledge in matters related to healthcare, the improvement of the healthcare system, and the quality of life of patients.
The objective and focus of the congresses or scientific events should be to provide scientific, educational and/or professional information, and to update; but under no circumstances should social and/or recreational activities be sponsored.
In order for a congress to be understood as “international”, most of the participants must be foreigners, and the relevant resource or expertise should be located abroad, being the main object of the event. In the case of organising or sponsoring of international events, member companies must also comply with the specific provisions of the relevant country, and the codes of good practice of the country where the event takes place in addition to CAEMe’s code of ethics.
When member companies organise or participate in events, this fact should be stated in all documents relating to the invitation, as well as in any paper or document to be published.
At these types of events, promotional items may be handed out; however, they should be related to the scientific and/or educational activities attended by HCPs – eg, articles that serve as containers of scientific information and/or that can be used by HCPs. However, under no circumstances may money be offered to compensate for the time spent by HCPs to attend the event (loss of profit). Additionally, the sponsorship of HCPs or any other actor of the health system may not be conditional on the obligation of their prescription, recommendation, purchase or promotion of a medicinal product, or to obtain an undue advantage in favour of the member company.
In Argentina, there are no legal rules specifically concerning the advertising of medicinal products on social media. Hence, advertising medicinal products on social media is subject to the same requirements imposed on traditional channels, as described in 7.1 Regulation of Advertising of Medicinal Products on the Internet.
National Law No 17,132 on the Practice of Medicine (which applies to the Autonomous City of Buenos Aires) and similar provincial anti-benefits regulations (following the national standard guidelines) set forth general principles, but do not regulate in detail restrictions on economic benefits, value of the content or agreements with content-generating vendors. Therefore, the pharmaceutical industry – including local and foreign laboratories – in Argentina has issued industry self-regulations with specific and modern standards to be followed.
The Practice of Medicine Act sets forth a general prohibition on HCPs obtaining any profit from pharmaceutical companies that would imply inappropriate influence on the prescription practices of an HCP.
The National Ministry of Health’s Resolution No 627/2007 on “Good Advertising Practices of Prescription-only Medicines” provides anti-bribery rules applicable to interactions between pharmaceutical companies and HCPs, prohibiting pharmaceutical companies from delivering any types of benefits, such as bonuses, pecuniary advantages or in kind, to HCPs. Their liability will extend to any person acting on their behalf and/or representation.
Also, the Argentine Criminal Code includes part of the Argentine anti-corruption legislation (Sections 256 to 259), which prohibits active and passive bribery of public officials as well as active bribery of foreign public officials. These regulations also apply to benefits provided to public HCOs. In this respect, CAEMe’s code of ethics sets forth that medical and scientific personnel working at a public or partially public hospital, clinic or university, or other similar public or partially public entity, will be considered “public officials”.
Additionally, CAEMe’s code of ethics provides that all relations with public officials must comply with applicable rules and regulations – ie, any rule or provision applicable to Argentine public officials or imposed by their employer. Member companies should adopt policies and procedures so that all relations with public officials occur in a justified and transparent way, and are duly documented and recorded. Therefore, companies may incur criminal liabilities for bribes offered or given to public officials by the companies’ employees, directors or other persons under their control, who may act in their name and/or representation.
The National Ministry of Health’s Resolution No 627/2007 on “Good Advertising Practices of Prescription-only Medicines” establishes the prohibition on pharmaceutical companies from granting, offering or promising to HCPs and/or to persons related or close to them any types of benefits of any nature, such as bonuses, pecuniary advantages or in kind, or of any other type.
CAEMe’s code of ethics stipulates that donations, grants or contributions in cash or in kind to HCOs are only permitted if:
Along the same line, the code of ethics provides that it is not permitted to give donations and/or grants to HCPs.
Conversely, the code of ethics allows the granting to HCPs of promotional items (also called merchandise or gimmicks) that are intended to serve as a reminder of the product brand and/or company logo only for over-the-counter products, as well as items of medical utility if they are of modest value, and informative or educational articles for the professionals’ and/or their patients’ education about diseases and their treatments, provided that the articles are primarily for educational purposes.
As mentioned in 8.1 General Anti-bribery Rules Applicable to Interactions Between Pharmaceutical Companies and Healthcare Professionals, companies may incur criminal liabilities for bribes offered or given to public officials by the companies’ employees, directors or other persons under their control, who may act in their name and/or representation. CAEMe’s code of ethics identifies a “public official” as any person holding an official position, including medical and scientific personnel when working in a public or partially public hospital, clinic or university, or other similar public or publicly owned entity.
As stated previously, the National Ministry of Health’s Resolution No 627/2007 on “Good Advertising Practices of Prescription-only Medicines” establishes the prohibition on pharmaceutical companies from granting, offering or promising to HCPs and/or to persons related or close to them any types of benefits of any nature, such as bonuses, pecuniary advantages or in kind, or of any other type.
Nonetheless, educational support may be granted to HCPs on an individual basis, such as rotations in reference health institutions, professional updating scholarships, and research support in reference health institutions, as long as they meet the requirements described in 9.3 Sponsorship of Scientific Meetings and payment is made directly to the educational provider involved.
Pharmaceutical companies may provide HCPs with free samples of medicines for the purpose of improving patient care. These samples may not be sold or used inappropriately.
Companies must have adequate control, tracking and follow-up systems for samples given to HCPs.
The samples provided to HCPs should be identifiable by the generic and commercial name, with the same size and prominence for both. In the case of medicines consisting of two or more generic names, the size of the typography for each of them may be reduced proportionally. They should also contain abbreviated information in approved labels and package inserts referring to indications, posology, adverse effects and contraindications, and should not add promotional expressions. Pharmaceutical companies should maintain an adequate control system verifiable through the production books.
Pharmaceutical companies are not allowed to provide samples of medicines containing psychotropic or narcotic substances or that may create dependence or generate public health problems due to their inadequate use.
The National Ministry of Health sets forth that pharmaceutical companies may grant scholarships to HCPs through training courses, participation in congresses, symposiums and strictly scientific meetings. Requirements include:
Also, CAEMe’s code of ethics provides that pharmaceutical companies are allowed to sponsor the attendance of HCPs at scientific meetings or congresses, provided that such sponsorship meets the following conditions:
Pharmaceutical companies must not pay for any costs related to persons accompanying the HCPs as guests.
Pharmaceutical companies are not allowed to organise or sponsor cultural, sports or other non-scientific events in relation to scientific conferences. Hospitality cannot include the sponsorship or organisation of entertainment or leisure activities.
As indicated in 9.1 Gifts to Healthcare Professionals, pharmaceutical companies are not allowed to grant, offer or promise, in their name and/or representation, to HCPs and/or persons related or close to them any types of benefits of any nature, such as bonuses, pecuniary advantages or in kind.
See 8.2 Legislative or Self-Regulatory Provisions as regards CAEMe’s code of ethics concerning permitted donations, grants or contributions to HCOs.
In Argentina, the grant of rebates or discounts to HCPs is expressly forbidden by Resolution No 627/2007 with respect to prescription-only medicines. This prohibits pharmaceutical companies from granting, offering or promising to HCPs and/or to persons related or close to them any types of incentives or benefits of any nature, such as bonuses, pecuniary advantages or in kind.
Also, see 8.1 General Anti-bribery Rules Applicable to Interactions Between Pharmaceutical Companies and Healthcare Professionals and 8.2 Legislative or Self-Regulatory Provisions for the restrictions applicable to rebates or discounts directed towards HCOs.
Pharmaceutical companies are allowed to pay for services provided by HCPs provided certain conditions are met.
In this respect, CAEMe’s code of ethics establishes the permission to hire HCPs individually or in groups for the provision of advisory or consulting services (ie, lecturers or moderators at meetings, training activities, expert meetings, etc). Fees paid to the HCPs should be based on market criteria and related to the time devoted, the work performed and the responsibilities assumed. It is mandatory to conclude a written agreement covering the lawful provision of this kind of service, which needs to include a provision pursuant to which the HCPs commit to state that they provide services to the company whenever they make a public statement about an issue that is the subject matter of their agreement with the company.
Hence, the payment of reasonable fees and reimbursement of expenses related to the provision of the service, including travel, to moderators and speakers at these meetings, congresses, symposiums and events of a professional or scientific nature is acceptable.
The National Ministry of Health sets forth that pharmaceutical companies may grant scholarships to HCPs through training courses, participation in congresses, symposiums and strictly scientific meetings, provided:
Besides this, no other prior authorisation is required from a regulatory authority for these activities.
The Autonomous City of Buenos Aires is the only jurisdiction that has issued a regulation on transparency obligations applicable to pharmaceutical companies. Act No 5,709 of the Autonomous City of Buenos Aires, issued in 2017, sets forth that manufacturers, importers and distributors of medicines have the obligation to inform the Ministry of Health of the City of Buenos Aires when they provide benefits or goods of pecuniary value to HCPs with offices or that undertake their activities in the Autonomous City of Buenos Aires.
Benefits or goods that fall within the scope of this obligation are:
The submitted information must contain at least the following data:
CAEMe’s code of ethics establishes that member companies should duly document, in accordance with their internal procedures, any transfer of value that they directly or indirectly make to health system actors. This includes, but is not limited to:
Likewise, the duty of documentation covers all donations or contributions that member companies make, directly or indirectly, to actors of the healthcare system.
There are no exceptions regarding the disclosure obligation due to COVID-19 incidences.
Foreign companies and companies that do not yet have products on the market are not subject to transparency regulations.
The responsibility for enforcing advertising and incentive rules lies with the national health authorities, in particular the ANMAT, the National Ministry of Health, the provincial health authorities and that of the Autonomous City of Buenos Aires. The ANMAT is the enforcement authority in charge of monitoring compliance with the Medicines Act and of receiving complaints for the respective infringements, under the terms of Decree 1490/92 and Decree 341/92.
CAEMe’s code of ethics is applied by its control committee and board of directors, with the power to control and sanction members in the case of infringements of the provisions of the code.
The ANMAT has a specific programme established by Disposition No 2845/2011 for the “Monitoring and Control of Advertising and Promotion of Products Subject to Health Surveillance”, which allows any interested party to file complaints online about medicinal advertisements. Complaints can also be made via email or telephone.
In the case of complaints to the ANMAT by a third party, or when the ANMAT detects non-compliance, the offender shall be notified by means of an injunction to cease the dissemination of the advertising and/or promotion involved. The ANMAT will also include such injunctions on the institutional website with public access, without prejudice to any other actions that may be applicable.
It should also be noted that any advertising that violates the Fair Trade Decree can be denounced by any individual or legal person, public or private, before the Secretariat of Commerce.
The company affected by an infringing advertisement made by a competitor may also take legal action before the courts, for non-compliance with the Fair Trade Decree. The following actions may be initiated:
The referred actions may be brought by any individual or company participating in the market, whose economic interests are directly harmed or threatened by the prohibited advertisement. They may also be brought by the following entities:
In the case of a complaint by an affected party, the latter may initiate the above-mentioned procedure before the Secretariat of Commerce, or choose to initiate legal action directly before the courts. However, if the affected party chooses to initiate the administrative procedure, once this has been initiated, the legal action will lapse, except for the action for damages.
CAEMe’s code of ethics stipulates that member companies – without prejudice to the direct request for the allegedly infringing member company to cease the dissemination of the advertising and/or promotion involved – undertake to raise before the compliance committee any complaints they may have against the promotional or health professional practices of other member companies in the first instance and prior to recourse to the courts or the health authorities, as well as to abide by and comply with the mediation agreements reached and the content of the resolutions of the committee.
The Medicines Act provides for the following penalties:
In practice, the sanctions generally imposed are warnings and fines.
The ANMAT will evaluate the sanction to be applied according to the seriousness of the offence and the particular background of the case and the offender. For this reason, if the rules on medicinal advertising or prescription inducement are not complied with, the ANMAT could, ex officio or in the framework of a complaint, initiate an administrative procedure and eventually impose a penalty.
Decisions taken by regulatory bodies may be challenged through an administrative appeal and through judicial review. Where the ANMAT initiates an administrative procedure for the application of the fine, it is mandatory to exhaust the administrative procedure prior to appealing the application of the fine before the courts.
CAEMe’s code of ethics regulates offences and sanctions according to the seriousness and background of the offender. It is thus established that sanctions will be suggested by the compliance committee to the board of directors, depending on the seriousness of the offence, and these sanctions may include:
CAEMe’s code of ethics states that, prior to raising the issue before the regulatory authorities or the courts, companies approaching CAEMe must first file their claims against the promotional practices of other companies before the bodies in charge of enforcing the code.
Notwithstanding the foregoing, the regulatory authorities mentioned in 11.1 Pharmaceutical Advertising: Enforcement Bodies may investigate matters on their own initiative, even if the issue is already being considered or measures have been taken by CAEMe.
During the last few years, there have been no significant (publicly known) cases regarding advertising of medicinal products.
However, in a notable publicy known case from 2013, the ANMAT decided to fine a pharmaceutical company for violating Section 19 (c) of the Medicines Act, which prohibits any form of advertisement of prescription-only medicines to the general public. The pharmaceutical company made an advertisement using a gigantography in which no brand of prescription medicines was incorporated, but the phrase “changing the future of diabetes”, among others, was included and signed by a famous polo player, as well as the company’s isologotype, telephone number and website address.
The ANMAT understood that, although the advertisement did not mention a particular pharmaceutical company, the mentioning of the pathology, and the company’s corporate name, telephone number and website induced the promotion of prescription-only medicines. Therefore, the enforcement authority fined the pharmaceutical company and its technical director for indirect advertising of prescription-only medicines.
In Argentina, there is a separate legal regime for advertising veterinary medicines.
The enforcement authority is the National Service of Agri-Food Health and Quality (SENASA), which is responsible for regulating and controlling veterinary medicines.
Consequently, the regulation on veterinary medicines differs somewhat from the regulation on human medicines. SENASA Resolution 1642/2019 is the main regulation on veterinary medicines, which expressly allows for advertising veterinary medicines, as long as such medicines and their indications are duly registered with SENASA, subject to the following restrictions. Veterinary products must not be described or presented with labels or advertisements which:
In general, the advertising of veterinary medicines is subject to the same requirements and principles as human medicines, since the information provided to the general public must be certain, objective, real, and must not mislead or confuse the consumers.
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The regulations on advertising of medicines provide that only over-the-counter medicines can be advertised to the general public and prescription medicines can only be advertised to healthcare professionals (HCPs).
The advertising of these products must comply with a series of general and specific guidelines. For instance, they must include the phrase “Read the prospectus carefully, and in case of any doubt, consult your physician and/or pharmacist” in a way that is visible and maintained for a period of time allowing consumers to read the full legend. The pharmaceutical company will be responsible for ensuring that the use of the name, attributes or messages related to the promoted products are appropriate, taking into consideration the particular characteristics of each advertisement.
The latest trends and developments in connection with pharmaceutical advertising in Argentina include the following matters:
This article analyses each of these matters, providing background information and relevant context when needed.
Advertising and Sale of Medicines Through the Internet and Social Media
The internet has had a major impact on the world of computing, communications, business, and naturally the advertising and commercialisation of goods and services (e-commerce). Through the internet, companies have found a tool to reduce purchasing costs and to speed up procurement, logistics and inventory, and production planning.
This new form of commerce has given rise to the phenomenon of the “virtual company”, which, through computer networks, advertises its goods and services, carries out transactions and also links up with other companies. For instance, in Argentina, “Mercado Libre” is a local platform through which people may offer and buy any kind of products, like with Amazon in the USA.
The increasing supply of medicines through websites, social networks and emails is a major concern of the health authorities. Under current circumstances, laws and regulations forbid the sale, purchase and dispensing of any type of over-the-counter medicines or prescription-only medicines through the internet. In this respect, the National Administration of Medicines, Food and Medical Technology (ANMAT) expressly requested that the general public not acquire medicines from unknown websites, since the quality of these medicines cannot be guaranteed.
The liability of internet intermediaries for advertisements included on their websites is a matter of debate, since Argentina does not have an applicable specific legal framework. However, there are judicial precedents that provide some certainty: the courts have ruled that internet intermediaries are liable in the case of omission or inadequate or unjustifiable late removal of an illegal advertisment, or the failure to adopt preventative measures to block them. This means that courts analyse the intermediary’s conduct to determine whether they have taken all the necessary precautions to remove advertisements that are deemed illegal from the moment they became aware of such ads, or to determine whether they have been negligent. Therefore, in Argentina there are no relevant precedents ruling that no intermediary should be liable for illegal content posted or shared by individuals on their platforms, or where an intermediary was found liable for content generated by third parties and published on its media regardless of whether or not such intermediary had knowledge of that content.
In this respect, in 2011 the ANMAT created the “Monitoring and Control of Advertising and Promotion of Products Subject to Health Surveillance Programme” (the “Programme”), which aims to monitor and evaluate advertisements in the mass media and specialised media with respect to products subject to sanitary surveillance, such as medicines. The Programme seeks to foster integration and interaction with other governmental agencies (both provincial and national), regulated sectors, NGOs and educational institutions, for the collaboration of advertising monitoring activities. Also, the Programme strengthens the link with consumers, who will be able to easily access all regulatory information.
Since 2012, due to the substantial increase of digital commerce, the Programme surveys advertisements and publications disseminated through the internet, with a particular focus on the most widely used marketing platform in the country, Mercado Libre. In 2020, the Programme surveyed around 68,000 advertisements promoting pharmaceutical products referring to COVID-19; and during 2021, thanks to more strict controls, the number of monthly surveys doubled in four months, causing the removal of lots of advertisements that were promoting unregistered medicines, or that included sales bans and misleading advertising.
For this purpose, the ANMAT has a collaboration agreement in place with Mercado Libre, to control the sale of medicines and other relevant health products through that virtual platform. The purpose of the agreement is to exchange information on the products regulated by the ANMAT (medicines, medical devices, dietary supplements and cosmetics, among others) that are offered for sale in Mercado Libre’s platform. In addition, the agreement also includes the provision of certain technical and legal advice by the ANMAT to Mercado Libre and mutual collaboration for the detection of advertisments that may infringe the regulations. There is an email address in place that is available for the delivery and processing of notifications and removal of notices posted on Mercado Libre’s website that infringe the legal framework, as per the ANMAT’s criteria.
Mercado Libre’s website expressly provides the following notice:
“If you have doubts about any product, first of all find out if it is legal to sell it. Basically, if the law does not allow it, neither do we. For example: pharmaceutical products, prescription medicines, endangered animals and many others.”
As a result of this collaboration agreement, the ANMAT and Mercado Libre cancelled appoprximately 1,600 advertisements corresponding to illegitimate pharmaceutical products or that were considered misleading advertising.
Under Argentine regulations, any form of promotion of medicines to the public, including through traditional or non-traditional media, would be considered advertising.
Even though there is currently no legal framework applicable to influencers or social media with respect to advertising of medicines, there is an advertising self-regulatory board (CONARP), which has issued general guidelines directed to those people promoting any types of goods and/or services on social media, including medicines. These guidelines are not compulsory but constitute good practices on advertising that should be followed.
In general, these guidelines provide the following:
It is worth mentioning that a legislative bill providing a legal regime for influencers in digital advertising services and electronic telecommunications networks was introduced in the Senate.
Visits by Medical Sales Representatives of Pharmaceutical Companies to HCPs
In Argentina, the visits carried out by medical sales representatives of pharmaceutical companies are deemed as promotion activities, since they supply to HCPs samples of the medicines offered at the market, in order for them to evaluate their characteristics, effects, and eventually, if they consider appropriate, to prescribe them. Promotion of any non-authorised medicinal product or off-label indication is forbidden. Sales representatives should not use any incentive or make any payment to obtain an interview with an HCP.
The regulations set forth that visits to HCPs carried out by pharmaceutical companies’ representatives should have the main purpose of informing about technical and scientific knowledge, adequate for the objective assessment of a therapeutic application. Pharmaceutical companies are responsible for establishing appropriate procedures for the training of medical advertising agents and/or medical propaganda in order to transmit and facilitate to HCPs all the information regarding the relevant therapeutic benefits, adverse effects, contraindications, interactions and others.
Since Argentina is a federal country with 24 jurisdictions, each of them has their own competence to rule on this subject, as follows:
Conflicts of Competence
In recent years, there have been a number of judicial cases in which the courts ruled on competence issues between the ANMAT and the enforcement authorities of Law No 24,240 (the “Consumer Protection Act”) and of National Decree 274/2019 (the “Fair Trading Decree”) in connection with medicinal advertising complaints.
In this regard, it is important to highlight that the ANMAT is the enforcement authority specially empowered by law to verify compliance with the provisions on medicinal advertisements. However, the Consumer Protection Act and the Fair Trading Decree provide general guidelines to be complied with for the advertising of any types of products and services, including medicines.
In particular, the Consumer Protection Act sets forth that suppliers are obliged to provide to consumers certain clear and detailed information on the essential characteristics of the goods and services, and the conditions of their commercialisation. Section 5 establishes that goods and services must be supplied or rendered in such a way that, when used under foreseeable or normal conditions of use, they do not present any danger to the health or physical integrity of consumers or users. Additionally, Section 8 establishes that the clarifications made in advertising or in announcements, leaflets, circulars or other means of dissemination are deemed to be included in the contract with the consumer and are binding on the offeror. In Argentina, patients are deemed consumers.
The Fair Trading Decree prohibits any kind of presentation, advertising or publicity that, through inaccuracies or concealment, may lead to error, deception or confusion concerning the characteristics or properties, nature, origin, quality, purity, mixture, quantity, use, price, marketing conditions or production techniques of goods, real estate or services. In turn, Section 15 sets forth the guidelines that determine when comparative advertising is allowed (these guidelines are similar to those established by ANMAT Disposition 4980/2005, which regulates the advertising of over-the-counter medicines).
Therefore, although these general rules do not refer specifically to medicines, they are mandatory for pharmaceutical companies. As a result, in recent years there have been some competence conflicts between the ANMAT and the enforcement authorities of the Consumer Protection Act and the Fair Trading Decree, on issues related to advertising of medicines.
In particular, it is worth mentioning a recent ruling of June 2022 in which the City of Buenos Aires Federal Court of Appeals confirmed that the authority in charge of controlling and supervising medicines advertisements is the ANMAT. The case started with an ex officio investigation of the enforcement authority of the Consumer Protection Act based on the analysis of an advertisement of a medicine, disseminated both in social networks and traditional mass media, since the information of the campaign infringed consumer protection regulations as the advertisement granted the medicinal product properties tending to modify physical appearance when, according to the prospectus, it was intended to counteract occasional constipation.
The Court ruled that the ANMAT was the agency empowered to determine whether the use of certain phrases included in the advertisement violated the specific regime and, in such case, to apply sanctions provided for in the regulations, since it is the authority in charge of controlling the advertising of over-the-counter medicines.
Similarly, in a previous case of December 2018, in which the regulatory agency of the former Law of Fair Trade intervened in a complaint for misleading advertising of a medicine, the Federal Contentious Administrative Chamber confirmed that the ANMAT is the competent agency for supervising medicinal advertising.
Latest Regulatory Changes
The most relevant regulatory change in relation to medicinal advertising occurred in 2016, when the ANMAT, through Disposition 9660/2016, established that, with respect to over-the-counter medicines, pharmaceutical companies are no longer required to submit to the ANMAT the advertising materials in advance. Some bills have been submitted to the Congress regarding the advertising of over-the-counter medicines, but they have not been further developed thus far.
It is also worth mentioning that there has been great expansion on the use of cannabis for medicinal purposes in Argentina. The Congress has passed Law No 27,350, which provides the legal framework for medical and scientific research on the medicinal, therapeutic and/or pain-palliative use of the cannabis plant and its derivatives. In this context, the ANMAT has authorised new medicines containing cannabis derivatives, specifically for the treatment of epilepsy. Also, the Congress passed Law No 27,669, which expands the use of cannabis for medicinal and industrial purposes. Cannabis medicines are prescription-only medicines, so as such they cannot be advertised to the general public, only to HCPs.
In addition, in 2022, the Ministry of Health created a new category of medicines called “cannabis-based plant products and their derivatives intended for use and application in human medicine”. Only pharmacies are allowed to dispense these medicines, and their condition of sale is “under prescription”, considering the nature and consequences of their misuse. The regulations prohibit the advertising and/or production, delivery and circulation of free samples, samples for professionals, samples without commercial value, or any other denomination of similar scope of these products.
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