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.

General Rules

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:

• Autonomous City of Buenos Aires – Health Law No 153;
• Buenos Aires – Medicines Law No 11,405;
• Cordoba – Pharmaceuticals Law No 8,302 and Disposition No 4/2008; and
• Mendoza – Medicines Law No 5,897.

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:

• ethical promotion of medicines; and
• interactions between CAEMe’s members (or their agents) and HCPs, HCOs, public officials, POs and other stakeholders, to ensure that these interactions are appropriate, ethical and transparent.

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:

• advertising directed to the general public;
• advertising directed to HCPs capable of prescribing or dispensing medicines;
• visits by medical sales representatives or informative agents of companies to HCPs capable of prescribing or dispensing medicines;
• supply of medicinal samples;
• sponsorship of promotional meetings which HCPs capable of prescribing or dispensing medicines attend;
• sponsorship of scientific, academic or update meetings attended by HCPs capable of prescribing or dispensing medicines; and
• promotional items provided in the course of medical visits and offered at events attended by HCPs.

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:

• a response by the medical department of a member company to spontaneous requests by an interested HCP related to non-authorised medicines or off-label indications, where the response expressly states that the medicine or therapeutic indication subject matter of the request has not been licensed in Argentina;
• adequate disclosure of scientific data regarding non-authorised drug substances or off-label indications in Argentina, at scientific events organised by third parties, such as national and international conferences and symposiums, provided they have no promotional purpose;
• public disclosure of information related to non-authorised medicines or off-label indications, to shareholders and other interested parties as required by current rules and regulations; and
• information or documents that member companies deliver to HCPs to be given to patients, with respect to certain medicines, which due to the complexity of dosage, route of administration, etc, require the supply of additional information, and provided such information is intended to improve treatment compliance.

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:

• it must be objective and truthful;
• it must not contain statements that affect the good name of third parties;
• it must be applied to similar or comparable products; and
• it must be scientifically supported in a publication.

In particular, based on the Fair Trading Decree, the comparative advertisement for the medicine should not:

• create confusion with the comparison;
• ridicule or denigrate the other product;
• distort the image of the other product;
• infringe upon the good name or prestige of third parties;
• attempt to create a situation of rejection towards the competitor’s products or its users;
• mention active ingredients not contained in the advertised product; and
• mention possible adverse or collateral side effects of active ingredients not contained in the advertised product.

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:

• the meeting must be a truly international scientific event with a significant proportion of speakers and attendees from countries other than the host country;
• promotional material (excluding promotional aids) for a pharmaceutical product that is not registered in the host country must be accompanied by a statement indicating the countries in which the product is registered and that the product is not registered in the host country;
• promotional materials concerning prescribing information (indications, warnings, etc) authorised in one or more countries other than that in which the event is held should be accompanied by an explanation indicating that the conditions of registration vary from one country to another; and
• the countries in which the product is registered must be identified and it must be made clear that it is not available locally.

As mentioned in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, CAEMe’s code of ethics:

• stipulates that no pharmaceutical product should be promoted with a commercial intention until a marketing authorisation has been granted by the enforcement authority; and
• describes certain delivery of information to HCPs that shall not be considered prohibited promotion of unauthorised medicines or indications.

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:

• the trade product’s name, as authorised in the registration certificate;
• the product’s active ingredient(s), which shall be expressed by its generic name(s) in compliance with Decree No 150/92; and
• the legend “read the prospectus carefully and at the least doubt consult your physician and/or pharmacist”, which must be presented in a way that it is clearly perceptible to the addressee and always horizontally, must be in accordance with the size used in the graphics, and must be easy to read.

Conversely, the following information is prohibited:

• encouraging indiscriminate use of the product, and providing exaggerations or responses not scientifically demonstrated;
• suggesting that the use of the product should be permanent and/or that the product has curative properties for chronic or incurable diseases, unless contemplated and/or authorised in its prospectus;
• suggesting that the product prevents disease and, therefore, proposing its use in healthy people to improve their condition, unless scientifically proven and specified in the indications;
• suggesting that the advertised product is the only alternative by terms such as “the product”, “the one of choice”, “the only one”, “the most frequently recommended”, “the best”, etc;
• using phrases that provoke fear or distress, and suggesting that the subject’s health will be affected if they do not consume the promoted product;
• including phrases such as “proven in clinical trials” which have not been recognised by the ANMAT, and “approved, endorsed or recommended by experts and/or institutions” when they do not have the documentation to accredit this;
• including messages such as “advertising authorised by the Health Authority” or “product endorsed by the Health Authority”, whether such authority is national or international;
• using messages that try to measure the degree of reduction of disease risk by taking the product, unless contemplated and/or authorised in its prospectus;
• including messages tending to mask the real essence of the medicine or indirect benefits by presenting it as a food, candy, cosmetic or other product that is not a medicine;
• being exclusively or mainly directed to minors, pregnant and/or breastfeeding women, unless the products have been approved for that purpose;
• having children refer to the product, who may not directly or indirectly promote it;
• claiming that a product is “safe” and/or “uniformly well tolerated”, or assuring that it is not toxic, that it has no side effects or risks of addiction, or including equivalent phrases which, due to their broadness or vagueness, lead to interpreting that the product has a non-existent and/or false attribute;
• suggesting that a medical act or surgical intervention is unnecessary, postponable or substitutable;
• suggesting that the safety or efficacy of the product is due to the fact that it is natural – for products obtained from substances of natural origin, the advertisement may only state “made (obtained) from substances of natural origin” or “with ingredients obtained from substances of natural origin”;
• claiming that the action or mode of action of the product is “natural”, or that it “naturally restores the functional state” or “naturally causes an effect” such as those that occur without the use of the product, thus assigning it a natural property;
• using false, alarming or misleading terms about changes in the human body caused by illness or injury;
• advertising a product or a modification of one already existing in the market as “new”, after two years have elapsed from the date of the beginning of its commercialisation to the public;
• encouraging the purchase of the product with the exclusive motivation of donation or humanitarian destination, in order to avoid unnecessary consumption of the product; and
• modifying the indications and uses contained in the labels and/or prospectus of the product.

CAEMe’s code of ethics allows member companies to interact with patients, patient experts, patient advocates and caregivers, observing the following guidelines:

• having a legitimate interest for the interaction;
• complying with current laws and regulations on personal data protection;
• no promotion of prescription-only medicines; and
• if a fee is paid for the provision of the service, such fee should be fair market value, and a written agreement should be entered into.

Conversely, CAEMe’s member companies may interact with POs in the following cases:

• providing collaboration in cash or in kind for educational, scientific or professional purposes – however, collaboration in kind through the delivery of samples or medicines is not allowed;
• development of joint activities or sponsorship of educational, awareness, early detection and disease prevention activities, and development of capabilities enabling POs to represent patient’s voices in the various spheres in which health-related issues are discussed;
• hiring of advisory and/or consultancy services; and/or
• sponsorship for PO representatives to attend events related to their condition, provided the primary goal of the event is professional, educational and scientific in nature or that it supports, in some other way, the mission of the PO.

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 product’s essential information according to the approved characteristics identification data, including at least the medicine’s:
1. generic and trade name;
2. quantitative and qualitative composition;
3. pharmaceutical form;
4. indications and contraindications;
5. adverse effects;
6. warnings and precautions;
7. dosage; and
8. holder’s name and address.
• The product’s prescription regime and dispensing conditions.

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:

• they are legally constituted and fiscally registered entities;
• they are carried out with the purpose of collaborating with healthcare, research, teaching/training, social or humanitarian assistance;
• they are made on the basis of written requests or acceptances by the entity, clearly describing the programme or project and its objective, including how patients will benefit and/or how the quality of patient care will be improved by their request, and indicating how the funds will be used;
• they are formalised in documents, and copies of these documents are kept by the member company;
• they do not constitute an incentive for the recommendation, prescription, purchase, supply, sale or administration of medicinal specialties; and
• the evaluation process and the approval of donations or grants will be outside the commercial, marketing or sales areas.

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:

• informing HCPs, in advance and publicly, of the conditions of access to the scholarships and the selection procedure, respecting equality and transparency; and
• that the selection must be made by academic or teaching committees, or department or service heads, if applicable.

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:

• the event complies with the accommodation and subsistence requirements;
• the sponsorship of HCPs is limited to the payment of travel expenses, accommodation, lodging and registration fees;
• no payment is made to HCPs for time spent attending the event;
• sponsorship of an HCP is not conditional on the HCP’s obligation to prescribe, recommend or promote a medicinal product; and
• all these values must be reasonable.

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:

• the companies inform the HCPs, in advance and publicly, of the conditions of access to the scholarships and the selection procedure, respecting equality and transparency; and
• the selection is made by academic or teaching committees, or department or service heads, if applicable.

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:

• payments in cash;
• payments of professional fees;
• payments to cover any professional training activity;
• payments to cover travel expenses; and
• issuance of securities, tickets, gifts, lodgings, entertainment, expenses, meals or any other property of economic value.

The submitted information must contain at least the following data:

• identification of the contributing company with indication of the products manufactured, imported or distributed;
• full name of the receiving HCP;
• the HCP’s specialty;
• nature of the incentive, and if applicable, the amount or payments made and/or the quantification of the transfers, contributions or gifts made; and
• the dates on which the payments, transfers, contributions or gifts were made.

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:

• fees paid for services rendered;
• collaboration provided for scientific and professional events; and
• hospitality expenses incurred in connection with an event, including the costs of transport, registration, accommodation and meals, and the provision of medical and scientific publications.

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:

• action to cease the advertising act, or to prohibit it;
• action for compensation for damages caused by the prohibited advertising – compensation may include the publication of the judgment; and
• injunctive relief.

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:

• associations, or professional or representative corporations, of economic interests, where the interests of their members are affected in accordance with the provisions of Article 10ter of the Paris Convention for the Protection of Industrial Property, approved by Law No 17,011; and
• associations whose purpose, according to their statutes, is consumer protection – in this case, standing shall be subject to the condition that the advertising directly affects the interests of consumers.

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:

• warnings;
• fines;
• total or partial, temporary or permanent closure, depending on the seriousness of the the offence;
• suspension or disqualification from the exercise of the activity or profession for up to three years (in the case of extreme seriousness or multiple reiteration of the offence or offences, the disqualification may be permanent);
• confiscation of the effects or products of the infringement, or of the compounds involving the elements or substances in question; and/or
• cancellation of the authorisation to sell and manufacture the products.

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:

• a warning;
• suspension of membership rights for a period of one month to one year, with maintenance of the obligations corresponding to the member’s obligations of their class of membership; and
• expulsion.

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:

• use words, denominations, symbols, emblems, illustrations or other graphic representations that could make the information false, incorrect, insufficient, or that may mislead, confuse or deceive the consumer as to the true nature, composition, origin, type, quantity, quality, duration, performance or manner of use of the product;
• attribute effects or properties to the product that it does not possess or that cannot be demonstrated; and
• use superlative terms or terms that induce comparison with other similar products registered by other registered individuals or entities – including words of other languages that are commonly used in Argentina.

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.