On June 8, 2020 the then Bureau of the Consumer Legal Protection (Dirección de Protección Jurídica del Consumidor) filed an ex-officio action, as a result of an advertising message of the laxative “Agarol Pür”, an “over-the-counter” medicine, because it considered, as stated in the accusation filed, that it would – presumably – infringe regulations that protect consumers’ rights.
The Bureau analyzed the commercial – in my opinion, in a lopsided manner – in the light of certain provisions of the (Emergency) Decree 274/2019, of Fair Commercial Practices, of Order ANMAT 4980/2005 and other regulations, most of them regarding healthcare, of which it is not the enforcement authority – in spite of lacking legal authority to do it – and it resolved to accuse the advertiser, owner of the product, of alleged infringements to sections 4th, 5th, 6th and 8th bis of Act 24,240, of Consumer Defense.
As I mentioned in the preceding paragraph, the Bureau lacks legal authority to issue the accusation in question, since it is not en enforcement authority especially empowered by the law to verify the compliance with the advertising of medicines provision, a power that exclusively and solely falls on the ANMAT.
I say the foregoing because Decree 1490/92, in its section 3, subsection e), has set up the ANMAT as the authority “to enforce the activities, processes and technologies carried out on the basis of the supply, production, manufacturing, fractioning, importation and/or exportation, deposit and commercialization of the products, substances, elements and materials consumed or used in human medicine, food and cosmetics.”
Resolution N° 20/2005 of the then Ministry of Health and Environment, set forth, in turn, that ”Every publicity or advertising addressed to the public of over-the-counter medicinal specialties and dietary supplements (…), whatever the media used for its broadcasting, shall comply with the ethical criteria provided for by the NATIONAL ADMINISTRATION OF MEDICINES, FOOD AND MEDICAL TECHNOLOGY (ANMAT)” (section 1st), setting forth that “every publicity or advertising addressed to the public of (such) products.” Would be supervised according to the system to be provided for by the ANMAT (section 2nd) and that the ANMAT would be the enforcement authority of the regime, empowering it for the issuance of the regulatory rules that it may deem necessary for its implementation (section 3rd), determining the penalties applicable to its infringers (section 4th) (emphasis added; it does not appear in the original).
In turn, Order ANMAT 2335/2007, created the Commission of Supervision and Control of Advertising (Comisión de Fiscalización y Control de Publicidad) of the over-the-counter medicinal specialties and others (section 1st), which duties are the following:
(i) evaluate the advertisings broadcasted in the media corresponding to any of the products included in section 1st of Resolution 20/2005, in order to control the compliance with the regulations in force on the issue;
(ii) propose the warnings to the parties responsible for the advertisings that are considered issued infringing the regulations, so that the infringing conducts are suspended and notwithstanding the other actions that may correspond;
(iii) issue technical reports, expressly describing the conducts considered in infringement based on the regulations in force, all of it to order -if applicable -, the filing of a health inspection, and
(iv) propose supplementary regulations, that modify and/or clarify the regulations on advertising control at present in force (section 2nd).
Subsequently, Order ANMAT 2845/2011, created the “Program to Keep Track of and Supervise the Advertising and Promotion of Products Subject to Health Surveillance” (section 1st), in charge of, among other duties, the evaluation of the advertisings broadcasted in the media corresponding to any of the products included in section 1st of Res. 20/2005 mentioned above, so as to verify the compliance with the regulations in force on the subject.
The regulatory overview made above, contained in the defense filed in due time by the accused advertiser in the case, clearly explains that the Bureau lacks legal authority to make any accusation whatsoever on advertising of medicines.
The ANMAT has the specific – and exclusive – legal authority to supervise the advertising activity related to medicines, pursuant to the regulations reviewed above, and it is reasonable because the ANMAT has the necessary aptitude for it.
In line with the foregoing, the Emergency Decree 274/2019 – claimed also by the accused advertiser, in its defense -, that issued the new Fair Commercial Practices regime, in its section 13 sets forth that the investigations, filing of summary proceedings or penalties related to advertisings regulated by entities with specific legal authority on the issue – just like in the case of advertising of medicines, regulated by orders of the ANMAT – excludes the intervention of the enforcement authority of said regulation.
On this respect doctrine has stated that “The spirit of the section is clear. In such sense -according to the provisions of section 3rd of Resolution20/2005- on advertising of medicines, the enforcement authority is the ANMAT”.[1] (Emphasis added).
Said conclusion is in line with the regulation of section 6th of Resolution 248/2019, which regulates Decree 274/2019.[2]
This is reflected also by case law, in several precedents, even before the issuance of said Emergency Decree 274/2019.
In said sense it has stated the following:
“Consequently, in view of such a clear regulation, there are no doubts that the Secretariat of Domestic Trade (Secretaría de Comercio Interior), National Bureau of Domestic Trade (Dirección Nacional de Comercio Interior) lacks legal authority to hear this specific case, in which the expert body, having specific legal authority assigned to control the advertising activity related to dietary supplements must intervene, i.e. the ANMAT is empowered to determine if the absence of the phrase “consult your medical doctor and/or pharmacist” -required in paragraph 1.5 of Annex IV (Specific Rules for Advertising Dieatary Supplements), of Order n° 4980/05, which section 16 abrogated the similar order n° 3186/99 that the defendant considered infringed – in the catalog of products of “Nutrilite” line violates the specific regime governing the issue and, if applicable, impose the penalties it considers relevant, a circumstance that determines the nullity of the punitive act objected to in this case, in accordance with section 14, subsection b), of Act 19,549.”[3] (Emphasis added).
Likewise, the: “National Bureau of Domestic Trade lacked legal authority to issue a decision in connection with the accusation that gave rise to the administrative proceedings since said initial presentation required a decision on an advertising related to a product contemplated in the categories individualized in Resolution N° 20/2005 issued by the Ministry of Health and Environment, while it must be highlighted that -on this respect- a specific legal authority has been assigned to the ANMAT to control the advertising activity related to the products included in said resolution of the Ministry of Health and Environment.”[4] (Emphasis added).
And that: “The latter (ANMAT) is empowered to determine whether or not the use of any of the phrases contained in the questioned advertisement violates the specific regime governing on the issue and, if applicable, to impose the penalties that it may deem relevant, since in the case it was considered that the specific advertising regime that governs the products included in resolution nº 20/2005 issued by the Ministry of Health and Environment, which supervision –I must insist- is n charge of the ANMAT, was not complied with. Under such conditions, it must be concluded that Order Nº 202/2015 issued by the National Bureau of Domestic Trade must be declared null because it is affected by the defect of lack of legal authority since the entity that issued said administrative act lacks the regulatory authority to impose penalties to the plaintiff for the actions individualized above (pursuant to section 7, subsection a, of the Administrative Procedure National Act (LNPA), what causes its invalidation (according to section 14, subsection b), of said legal regulation).”[5] (Emphasis added).
It must be highlighted that the fact that it is intended to set the grounds of the accusations on the alleged infringements on the Consumer Defense Act because, according to the Bureau, they would violate Order ANMAT 4980 and other regulations, most of them regarding health, which decision does not correspond to the Bureau either, does not impair – but makes clear – the Bureau’s lack of legal authority to issue the administrative act in question.
Not only because it lacks legal authority to investigate, file summary proceedings and punish advertisings of medicines, an exclusive and sole legal authority of the ANMAT, but because all the alleged reported infringements depend on the alleged infringement of regulations– basically regarding health – that are not within the Bureau’s legal authority.
In this sense, with the accusation for alleged infringement to section 4th of Act 24,240 it was intended to set the grounds on the fact that the Bureau considers that some of the phrases of the advertisement prove to be misleading under the terms of section 11 of the Emergency Decree 274/2019[6] and infringes Order ANMAT 4980/2005.
The accusation for alleged infringement to sections 5th and 6th of Act 24,240, intended to set the grounds thereof in alleged violations t o specific rules that regulate the subject, like the Order ANMAT N° 4980/2005, the provisions contained in Act 26,396, on Eating Disorders and Decree 274/2019, on Fair Commercial Practices.
And, finally, the Bureau intended to support the accusation for alleged infringement to section 8th bis of the Consumer Defense Act, on what it considers an infringement to section 5th of Act 26,485, on Integral Protection of Women.
In short, to decide the accusations of alleged infringements to the Consumer Defense Act, the Bureau basically analyzed – with its particular criterion – the compliance with Order ANMAT 4980/2005 and other health regulations, other than the Consumer Defense Act, hence attributing to itself powers that exceed – completely – its legal authority.
On this respect it must be pointed out that the Enforcement Authority of Decree 274/19 is the Fair Commercial Practices Bureau (Dirección de Lealtad Comercial); the Order ANMAT 4980, the ANMAT, Act 26,396, the Ministry of Health and Act 26,485 the National Council of Women (Consejo Nacional de las Mujeres). In other words, under no circumstances the Bureau is the Enforcement Authority.
In spite of the fact that the lack of legal authority of the Bureau to file accusations and its consequent nullity as well as any eventual punishing order derived therefrom is evident, the National Bureau of the Consumer Defense and Consumption Arbitration (Dirección Nacional de del Consumidor y Arbitraje del Consumo), through Order 506/2021, issued on July 15, 2021, imposed upon the advertiser a fine of AR$ 4.000.000 (Four million Argentine Pesos), without including in said Order any additional argument to the – to say the least – very weak dogmatic statements that intended to set, only in an apparent manner, the accusation.
What concerns us here, i.e. the Bureau’s lack of legal authority to judge alleged infringements on the advertising of medicines, in Order 506/2021 it was dogmatically stated, without considering the regulatory framework on advertising of medicines and forgetting the provisions of section 13 of Decree 274/2019, that the Bureau has legal authority to verify that the advertisements of medicinal products “… contain detailed, certain and true information, and that they do not lead to a use that may be potentially detrimental to health and consumers…”
The truth is that the Bureau has not the necessary technical knowledge to do it.
Nor that it has either – of course – legal authority for it.
As intended grounds – once again, only apparent – of its alleged legal authority, Order 506 quotes a judgment dated December 23, 2014, in which Panel II of the National Appellate Court having jurisdiction in Administrative Litigation Matters resolved a case related to the abrogated Act 22,802, on Fair Commercial Practices, on labeling and advertising of food.
Forgetting – more likely, hiding – that the regulation that replaces the Fair Commercial Practices Act (Emergency Decree 274/2019) contains an order that Act 22,802 did not have and that – as I mentioned above – determines that the filing of summary proceedings or penalties related to advertisements that are regulated by entities with specific legal authority on the issue – such as in the case of advertising of medicines, regulated by the ANMAT’s Orders – excludes the intervention of the enforcement authority of said regulation.
And what it should have done, pursuant to the provisions of section 6th of Resolution 248/2019, regulating Decree 274/2019, is to refer the administrative cases to the ANMAT within ten (10) administrative working days from its filing for its processing by said Administration.[7]
In short, the only administrative entity with legal authority to analyze and issue a decision on the legality of advertisements of medicinal products is the National Administration of Medicines, Food and Medical Technologies (ANMAT).
Neither the Bureau of the Consumer Legal Protection (Dirección de Protección Jurídica del Consumidor) nor the Consumer Defense and Consumption Arbitration National Bureau (Dirección Nacional de del Consumidor y Arbitraje del Consumo), nor any other national agency.
I highlight, in addition, even when it is not the subject of this work, that – in my opinion – none of the alleged infringements whereby the Bureau imposed the penalty upon the advertiser appear in the case. As from an improper regulatory analysis, that is not within its legal authority and technical capacities, and of weak conclusions, that prove its lack of specialization on medicines.
Against Order 506/2021, the advertiser filed a direct appeal, under the terms of section 45 of Act 24,240, that was resolved by Panel I of the National Appellate Court having jurisdiction in Administrative Litigation Matters on June 9, 2022, declaring the nullity of the objected to Order and ordering the Bureau to refer the case to the ANMAT, in order that, by exercising its specific legal authority, it may intervene in the administrative file according to the right to which it is entitled.
When examining the claim of lack of legal authority filed by the appellant, the Appellate Court made a review of the regulations involved in the case, in which it quoted the same regulations on which the advertiser based its petition for nullity.
Hence, the judgment reads as follows:
“i. Decree 1490/1992 provides that “the National Administration of Medicines, Food and Medical Technologies (ANMAT) shall have legal authority in all matters referred to: a) control and supervision of the health and quality of drugs, chemical products, reagents, pharmaceutical forms, medicines, diagnosis elements, materials and biomedical technology and every product of use and application in human medicine” […] c) surveillance on the efficiency and detection of adverse side effects resulting from consumption and use of the products, elements and materials comprised in subsections a), b) and c) of this section […] that may affect people” […] e) the control of activities, processes and technologies made on the basis of the supply, production, manufacturing, fractioning, importation and/or exportation, deposit and commercialization of the products, substances, elements y materials consumed or used in human medicine, food and cosmetics” (section 3rd). Likewise, it sets forth that the ANMAT “will be the enforcement authority of the legal regulations governing the matters subject to its legal authority, those issued in the future and those that by virtue of the powers conferred upon them be issued by the MINISTRY OF HEALTH AND SOCIAL WELFARE and the SECRETARIAT OF HEALTH, with regard to the scope of action of the Administration” (section 4th).
ii. Resolution nº 20/2005 —“Advertising for over-the-counter products”— of the then Ministry of Health and Environment sets forth that: “All advertising or publicity addressed to the public of over-the-counter medicinal specialties and dietary supplements, as well as of dental products, diagnosis reagents, cosmetics, medical technology devices, domisanitary products and food as determined by the enforcement authority, whatever the media used for its broadcasting, shall comply with the ethical criteria provided for by the NATIONAL ADMINISTRATION OF MEDICINES, FOOD AND MEDICAL TECHNOLOGY (ANMAT)” (section 1st). “Every publicity or advertising addressed to the public of the products mentioned in Section 1st of this resolution, shall be subject to the supervision following its broadcasting, according to the system to be duly provided for by the ANMAT depending on the media in which the advertising is broadcasted“ (section 2nd). “The [ANMAT] would be the enforcement authority of this resolution, and it will issue the regulatory, clarifying and interpretation rules that prove to be necessary for its implementation (section 3rd).”
iii. The order ANMAT nº 2335/2007 set forth that: —“The Supervisory and Control Commission of Advertising of over-the-counter medicinal specialties, dietary supplements, dental products, diagnosis reagents, cosmetics, medical technology devices, domisanitary products and food listed in Section 1st of Resolution 20/2005” issued by the Ministry of Health and Environment (section 1st) is created within the scope of the National Administration of Medicines, Food and Medical Technologies (ANMAT), —“It is ordered that the duties of the Evaluation Commission of [of said commission] will be the following: a) Evaluation of advertisings broadcasted in the media corresponding to any of the products included in section 1st of Resolution Nº 20/05 issued by the Ministry of Health and Environment, in order to control the compliance with the regulations n force on the subject …” (section 2nd). —“The entity ‘Argentine Consumers Association for the Consumer Defense, Education, Information’ (Consumidores Argentinos, Asociación para la defensa, educación, información del consumidor)’, is authorized to appoint a representative to participate in the meetings of the Commission created by this Order” (section 6th).
iv. The Order ANMAT nº 2845/2011, that abrogated order nº 2335/2007, contemplates: —“The creation within the scope of the Bureau of Planning and Institutional Relationships (Dirección de Planificación y Relaciones Institucionales) of the ‘Program to Keep Track of and Supervise the Advertising and Promotion of Products Subject to Health Surveillance” (section 1st). — “The Program shall have the following duty” (section 2nd): “—Evaluate the advertisings issued in the media corresponding to any of the products included in section 1st of Resolution Nº 20/05 issued by the former Ministry of Health and Social Welfare and specialized media promoting the products included in Resolution Nº 627/07 issued by the Ministry of Health, in order to verify the compliance with the regulations in force on the subject”. “—To notify the responsible parties of the advertisings considered issued in infringement of the regulations, so that they suspend the violating conducts, notwithstanding the other actions that may correspond”. “—To issue technical reports. With the express description of the conducts considered an infringement and based on the regulations in force, in order to order the filing of the relevant health summary proceeding …”
And likewise, it added:
“v. Order nº 6516/2015, of the Ministry of Health (Secretariat of Policies, Regulation and Institutes – ANMAT (Secretaría de Políticas, Regulación e Institutos—ANMAT) provides that: —“It is set forth that the companies owning products subject to sanitary surveillance shall notify this NATIONAL ADMINISTRATION on every advertising (whether traditional or not) addressed to people in general and to present the relevant advertising piece in the format to be broadcasted, in the case of advertisings of the following categories: a) over-the-counter medicinal specialty …” (section 1st). —“In case of an alleged infringement to the regulations in force on advertising matters, this NATIONAL ADMINISTRATION shall send the relevant warnings to the companies owning the products so that they suspend the broadcasting of the advertising and/or promotion involved, including said warnings in the institutional web site, notwithstanding the other relevant actions” (section 7th). —“According to section 5th of the Resolution of the former Ministry of Health and Environment N° 20/05 infringements to the provisions contained n this Order, shall make the owner of the product and its technical director liable, when applicable, to the imposition of the penalties provided for in Acts Nº 16,463 and N° 18,284and Decree N° 341/92” (section 9th).”
To conclude that, “… within the described regulatory context, the objected resolution nº 506/2021 is unlawful. This is so because, in the case, the DNCYAC lacks specific legal authority to control the advertising activity related to the over-the-counter medicinal products, like the product “Agarol Püre”, since said legal authority has been assigned to the ANMAT…” (Emphasis added).
As a support of its regulatory analysis, Panel I quoted the judgments of Panel III, regarding the cases captioned “Johnson y Johnson de Argentina SACEI v, National Bureau of Domestic Trade, Fair Commercial Practices —Act 22802—section 22”, “Goodtimes Group S.A. v. National Bureau of Domestic Trade, Fair Commercial Practices —Act 22802—section 22” and “Genomma Laboratories Argentina SA v. National Bureau of Domestic Trade, Fair Commercial Practices —Act 22802—section 22”, decisions dated November 11, 2014, November 10, 2015 and December 26, 2018, the three of them related to the advertising of medicines.
The Panel points out, in addition, that said decisions are final. Since the Supreme Court of Justice of the Nation declared that the extraordinary appeals filed by the National Government were inadmissible, claiming section 280 of the Civil and Commercial Code of Procedure of the Nation, according to the decisions dated September 27, 2016, November 6, 2018 and November 21, 2019.
In other words, the judgment provides for – again – that the Consumer Defense Bureau has no legal authority to analyze, investigate, file summary proceedings or impose punishments to the advertising of medicines.
The foregoing, due to the fact that it is not the enforcement authority especially empowered by the law, a duty that exclusively and solely corresponds, to the ANMAT.
Buenos Aires, July 7, 2022.
[1] Franco Rizzo Jurado, “Advertising of medicines and the new regime of Fair Commercial Practices” (La publicidad de medicamentos y el nuevo régimen de Lealtad Comercial), Special Supplement of Unfair Competition (Suplemento Especial de Competencia Desleal), Printing House Thomson Reuters – La Ley, August 2019, page 335.
[2] Setting forth that “When it suggests that the alleged advertising infringement must be judged by another national entity having specific legal authority on the issue, the administrative record shall be referred to the relevant entity within TEN (10) administrative working days for its processing.”
[3] National Federal Appellate Court having jurisdiction in Administrative Litigation Matters, Panel I, 08/16/2011, “Airway Argentina Inc. (Sucursal Argentina) v. National Bureau of Domestic Trade – Order 186/10” (File S01 380828/07), Quote: MJ-JU-M-69842-AR | MJJ69842.
[4] National Federal Appellate Court having jurisdiction in Administrative Litigation Matters, Panel III, 12/26/2018, “Genomma Laboratories Argentina S.A. v. National Bureau of Domestic Trade, Fair Commercial Practices – Act 22,802 – section 22”, La Ley dated 2/4/2019.
[5] National Federal Appellate Court having jurisdiction in Administrative Litigation Matters, Panel III, 10/11/2015, “Goodtimes Group S.A. v. National Bureau of Domestic Trade, Fair Commercial Practices – Act 22802 – section 22”, La Ley, Online Quote: AR/JUR/61718/2015.
[6] Which section 13, as I mentioned above, provides for that the investigations, filing of summary proceedings or penalties related to advertisings regulated by entities with specific legal authority on the subject– like the case of medicines, regulated by orders of the ANMAT -excludes the intervention of the enforcement authority of said regulation.
[7] Setting forth that: “When it suggests that the alleged advertising infringement must be judged by another national entity having specific legal authority on the issue, the administrative record shall be referred to the relevant entity within TEN (10) administrative working days for its processing.”