Pharmaceutical Advertising 2020

Last Updated March 02, 2020

Ecuador

Law and Practice

Authors



Meythaler & Zambrano Abogados is one of the most prestigious law firms in the Ecuadorian market. Founded in 1995, the firm specialises in national and international legal-counselling and litigation for international and domestic corporations. The firm's highly qualified team focusses on regulatory counsel (pharmaceutical, medical, food and cosmetic, in addition to agricultural sectors), intellectual property, competition and antitrust, arbitration and mediation, corporate and commercial affairs, dispute resolution, taxes, public procurement and public law. The firm has offices in Quito and Guayaquil that work across Ecuador, and belong to a wide network of correspondents throughout America, Europe and Asia. The firm is part of the International Bar Association (IBA), the International Trademark Association (INTA), the Intellectual Property Association (ASIPI) and the Ecuadorian Associations of Mediation and Taxation Law.

The laws and codes that regulate the advertising of medicines in Ecuador are vast and broad. The main regulatory bodies are: the Organic Law of Health, the Regulatory Treaty of Medicines ALBA, the Organic Statute of the Regulatory and Sanitary Surveillance Agency, the National Policy of Medicines Applied in the system of Health, the Resolution on Procedures Marketing of Medicines in General and Biological and the Ministerial Agreement 179 on the Promotion of Medications in General.

In Ecuador, there is self-regulation regarding the promotion and advertising of medicines, which has been formulated and put into effect by associations or unions, especially multinationals in the pharmaceutical research industry. When dealing with self-regulation, and being dependent on an association, it applies to the industry, particularly to companies that are part of that association

These instruments have taken great importance for associations, their members and for the State that recognises the importance of self-regulation of companies in the ethical sense and how this makes a difference in transcendental issues such as access to scientific information, the promotion of products and the interaction of the industry with the different actors of the health system, be these officials, patients or associations, promotion of medicines. It is for this reason that several of the concepts of self-regulation and Codes of Conduct have been included in the draft Organic Health Code

Regarding the legal value of the rules imposed by self-regulation, in the first instance they are part of the internal regulation and norms of ethics and anti-corruption (Compliance Standards). However, many of the principles established in self-regulation have been inserted in the Organic Code of Health that is being discussed in the National Assembly.

Advertising is defined as any form of computer offer, written, visual and others, aimed at the general public, and aimed at promoting the prescription, dispensation, sale, and use or consumption of over-the-counter (OTC) medications. Moreover, it is a commercial activity that is subject to the control of the Health Surveillance Authority, characterised by delivering commercial information of a specific medicine that must correspond to its true nature, composition, quality or origin, among others, in order not to induce the consumer in an error. 

In Ecuador, the advertising of medicines subject to prescription is prohibited.

The difference between advertising and information lies in its purpose. Advertising has economic purposes, seeking the increase in sales, and informing on the benefits of a particular medicine. Information, however, is aimed at training without being tied to a specific product or brand. Patient programs are not part of an advertising campaign, as long as it does not seek to profit in any way from the same and does not tie or relate the brand to the initiative.

One important clarification to note is that, in relation to leaflets for the patient, this is part of the labelling of the medicine. They are subject to the prior approval and control of the Health Authority and are not considered as part of the advertising.

The Ministerial Agreement 179 regulates the Promotion of Medicines in General. Article 9 authorises the advertising of medicines through the press, for medicines that are classified as over-the-counter products, as long as they are processed natural products for medicinal use, homeopathic medicines, or medical devices.

In the past, the authorisation of the Health Authority was required to carry out such advertising through the means of communication described. However, currently and after the entry into force of the Communication Law, the requirement of obtaining this authorisation was abolished. The new Communication Law that facilitated the advertising of over-the-counter medicines through the press was published on 20 February 2019.

The only pharmaceutical products that can be advertised through the press are over-the-counter medications; those that are not subject to medical prescription.

Comparative advertising is allowed as long as it meets the following parameters:

  • the object of the advertising must be medicines, processed natural products for medicinal use, homeopathic medicines, and medical devices, over the counter;
  • advertising must be based on authentic studies and information. It is a requirement that the studies that serve as the basis for advertising have been part of the dossier used to obtain the sanitary registration;
  • advertising should promote the rational use of medicines;
  • the information given by the advertising has to be complete and do not generated confusion or induce to the consumer in error. The information contained in the advertising material cannot induce misleading interpretations capable of causing a false, erroneous and/or confusing interpretation in relation to the drug, processed natural products for medicinal use, homeopathic medicines and medical devices;
  • the information given by the advertising has to be clear and accessible;
  • the advertising must indicate the therapeutic indications or uses of the medicine, which must be written in Spanish using clear language that does not generate confusion for consumers;
  • information disclosed must be reliable, accurate, true, up-to-date and in accordance with the therapeutic indications;
  • adjust to the content of the provisions of the health registration certificate as well as the pharmacological report issued by the ARCSA (National Agency for Health Regulation and Control) during the obtaining of said sanitary registration;
  • use of phrases and images must be in accordance with the condition or use of the product in accordance with the pharmacological report approved by the ARCSA (National Agency for Health Regulation and Control) during the obtaining of the sanitary registry, to favour the understanding of the general public;
  • advertising may not use expressions that cause fear or anguish, or suggest that health may be affected by not using the medication; and
  • advertising must obey the regulation of competence and it must not be misleading, subliminal or unfair to competitors. In the current Regulation, the offensive comparison for other brands, products, services, companies or organisations is expressly prohibited.

However, legal rules such as codes of conduct establish that, if comparative advertising is issued, it must be based on scientific information and comparative studies of molecules or products.

Information on medications that are not authorised for sale and distribution in Ecuadoris allowed only if it is for training purposes or the mere provision of information regarding a medication. This type of activity cannot be directed towards the general public. It is restricted to health professionals, the scientific community and other related parties only. The general public should not have access to, nor receive, any information or data of this nature from a member of the health industry.

The advertising of medicines whose marketing has not been authorised by an Ecuadorian competent authority is not allowed.

The provision of information on unauthorised medicines or indications is allowed during scientific conferences for healthcare providers, as long as the only objective to share such information is of an academic nature. The information must be clear and related to the conference being provided.

At this type of event, it is not allowed to refer to trade names or certain brands of drug as this could be confused as advertising or promotion which is not allowed prior to the authorisation of commercialisation.

The delivery of information to health professionals in Ecuador is executed through a medical visit or promotion. Active promotion is allowed under the Organic Health Law only for legally obtainable medications; that is, those that have an approved sanitary registry. In conclusion, information on medications or non-approved therapeutic indications can be provided to health professionals only in a reactive manner.

Health Institutions can only quote and request medications that are authorised.

The delivery of information is allowed, as well as the supply, importation and provision of medicines without a sanitary registration only in cases of sanitary emergency, for specialised treatments not available in the country, for treatments of catastrophic, rare or orphan diseases, for the purpose of Human clinical research, for the supply of the public sector through international organisations, in the case of donations accepted by the national health authority, or other cases defined by the national Health Authority.

However, each case will be analysed and a way to accelerate the authorisation process by the Health Authority in the market will be sought.

Compassionate use is an unregulated figure in local legislation. Regarding early access to a drug, it is understood that it is about availability of the drug before its marketing has been authorised. Access to unauthorised pharmaceutical products is allowed only in cases of sanitary emergency, for specialised treatments not available in the country, for treatments of catastrophic, rare or orphan diseases, for purposes of human clinical research, for the supply of the public sector to through international organisations, in the case of donations accepted by the national health authority or other cases defined by the national health authority. These cases, which are exceptional, are analysed individually and have specific patients as beneficiaries.

As a consequence of the above, there is no express rule that allows the availability of compassionate use programs or other forms of early access to be published.

The prohibitions of public advertising in general are prescribed in AM 179, which is comprehensive and includes the following:

  • advertising of medicines, processed natural products for medicinal use, homeopathic medicines and medical devices whose mode of sale is under medical prescription;
  • campaigns aimed at the general public that induce the use of prescription medications;
  • advertising carried out through containers, labels, labels, packaging, inserts or leaflets of other products that accompany medicines, processed natural products for medicinal use, homeopathic medicines, over-the-counter medical devices;
  • offensive comparison for other brands, products, services, companies or organisations;
  • to induce the indiscriminate use of the product, or answers not scientifically proven. That suggests that the intake of the product should be permanent;
  • that the product has healing properties in chronic diseases;
  • to suggest that the product prevents the disease and recommends its use in healthy people to improve its condition;
  • to induce to interpret that the product used is the only alternative expressing phrases and/or slogans that are not covered in the corresponding sanitary registry as: "the product of greater choice", "the only one", "the most frequently recommended", "the best", "totally reliable"; "the most effective", "famous", "totally safe", "is good", "new" among others;
  • that the advertising content includes minors, with the exception of those medications that are addressed to them and that there is a written authorisation from their parents, in accordance with the provisions of the Childhood and Adolescence Code Article 52;
  • include phrases such as "demonstrated in clinical trials", "clinically proven", "recommended by experts and/or institutions"; in the case of the use of these phrases, the scientific technical information that justify its use and that are duly approved by the INH in the process of obtaining the sanitary record must be attached to the request;
  • when it includes messages such as: "authorised by the National Health Authority", "Ministry of Public Health";
  • that the advertising induces the use and consumption of medicines, processed natural products for medicinal use, homeopathic medicines, and medical devices based on offers of offers and prizes, including associations with other products
  • uses of censored images (naked or half-naked) that promote the acquisition of the products;
  • if images and names of health professionals who recommend the use of the medication are used;
  • advertising carried out directly in shopping centres, sporting events, public shows, and other similar ones;
  • when it affects the image of other products, or threatens the good name of the products or prestige of third parties;
  • when you try to create a situation of rejection of competing products or their users;
  • when it mentions active ingredients not contained in the advertised product;
  • when it mentions possible adverse or collateral effects of active ingredients not contained in the advertised product;
  • advertising of medicines, processed natural products for medicinal use, homeopathic medicines and medical devices, carried out by pharmaceutical establishments and marketing of these products, without having the authorisation granted by the General Directorate of Health through the Directorate of Control and Improvement in Health Surveillance.

The advertising of the over-the-counter medicines that can be made to the public must have complete, suitable, supported, current and clear information, in Spanish.

The advertising of over –the counter medicines must contain the following information:

  • name of the product, which must correspond to the one stated in the certificate of sanitary registration;
  • pharmaceutical form, when applicable;
  • posology, when applicable;
  • precautions for use;
  • contraindications established in the pharmacological report, or in current pharmacological standards;
  • the warning: "If symptoms persist consult your doctor", if applicable.

In addition, the information that reaches consumers cannot be misleading

The Patient Organization is independent and is not conditioned in any way by the other health agents. In this sense, any type of program or benefit to the Patient Organization must be transparent through the competent authority and before the same industry that self-regulates. In this sense, the multinational pharmaceutical industry, in an organised way, has assumed self-regulation compliance rules, materialised according to IFPMA standards, which ensures that the actions of companies do not generate undue or inappropriate advantages.

The interaction with patient organisations is not regulated by the State but is part of the self-regulation of the pharmaceutical industry. With regard to restrictions on the interaction between patients or patient organisations and the industry, we have the following specific prohibitions:

  • do not induce the prescription and incorporation or exclusion of medicines in the basic tables of public institutions, and equivalent mechanisms for their own or third-party benefit;
  • do not induce the purchase of a medicine or health input by institutions of the Health Sector; and
  • do not ask Patient Organizations to be dependent on a member, demanding exclusivity in sponsorships.

All advertising directed at healthcare professionals must contain the therapeutic indications or uses of the medicine, and must be identical to the information provided to the competent authority to obtain the sanitary registry.

Confusing language that may cause misinterpretation cannot be used, nor expressions that cause fear of distress or suggest that health may be affected by not using the medication. Furthermore, the advertised product may not be offensively compared with any competition product.

All advertising must be based on the information provided to obtain the sanitary registration, including the Summary of Product Characteristics. However, additional data on file or other clinical studies not included in the Summary of Product Characteristics can be provided to healthcare professionals, but not as advertising.

All advertising must be based on the information provided to obtain place on the sanitary registry. This includes the Summary of Product Characteristics.

Reprints of journal articles may be provided to healthcare professionals for educational purposes as long as the information contained in the articles were used to obtain the sanitary registration.

Informally, Medical Science Liaisons can proactively discuss scientific information on unauthorised medicines or indications with healthcare professionals as long as they are not pharmaceutical sales representatives.

In the past, the authorisation of the Health Authority was required to carry out such advertising through the means of communication described. However, currently and after the entry into force of the Communication Law, the requirement of obtaining this authorisation was abolished. The new Communication Law that facilitated the advertising of over-the-counter medicines through the press was published on 20 February 2019.

To advertise products to healthcare professionals, pharmaceutical sales representatives must have professional training in careers related to health and pharmaceuticals sciences. They must also wear the corresponding identification during any medical visit.

No specific rules apply to advertising medicinal products on the internet but do enter the scope of regulation described in 6.1 Requirements for Prior Notification/Authorisation.

Currently, no specific rules apply to advertising on social media. Furthermore, the content made by citizens on social media are excluded from the scope of regulation and administrative control.

Companies are not required to include access restrictions on websites containing advertising or other information intended for healthcare professionals because only pharmaceutical sales representatives can advertise their products by visiting the healthcare professionals. However, the pharmaceutical industry does restrict itself when providing some sensitive information to the healthcare professionals that should not be disseminated to the general public. 

Companies are not allowed to provide disease awareness information to patients online.

It is strictly forbidden to advertise/promote pharmaceutical products to healthcare professionals who work in the public sector or public healthcare organisations.

Although there are no general anti-bribery rules that might apply to interactions between pharmaceuticals companies and private healthcare professionals or organisations, the main criminal offenses that could arise between pharmaceuticals companies and public healthcare professionals or organisations are bribery and what could be understood as a form extortion called “concusión”.

Concusión” occurs when public employees or people acting under a state of power in any of the State institutions, its agents or official dependents, abuse their position by ordering or demanding the delivery of fees, contributions or wages otherwise not due with the intention of preferential treatment of the pharmaceutical products of one company over another. It is punishable with imprisonment of up to seven years. 

On the other hand, the same people referred to in the previous paragraph that receive or accept improper economic benefits to boost one pharmaceutical company over another can be sentenced to prison up to seven years.

The current Regulations for Publicity and Promotion of Medicines, Processed Natural Products for Medicinal Use, Homeopathic Medicines and Medical Devises, which regulate the subject, does not prohibit offering benefits of other inducement to healthcare professionals or organisations.

The only prohibitions are those that might be subject of the criminal offenses described previously.

The offering of gifts or other items is not regulated by the State but is part of the self-regulation of the pharmaceutical industry, as follows:

  • gifts for personal gain are prohibited;
  • promotional items are prohibited in the case of RX products and allowed OTC if it is relevant to the practice of medicine;
  • medical utility items can be delivered twice a year, at most, and are allowed to do so only if they do not compensate for routine business practices that are beneficial to improve the provision of medical services; and
  • informative or educational items are allowed provided they are primarily for educational purposes and have no independent value.

All gifts have restrictions on value, which must be modest and adequate.

There are certain limitations that subject pharmaceutical companies providing samples to healthcare professionals, such as the ban on delivering biological medicament samples, the duty to mark samples in such a way so that they cannot be sold or improperly used, the responsibility to deliver small quantities of samples only to healthcare professionals authorised to prescribe that product, the duty to register and document sample deliveries and the obligation to verify that storage conditions are adequate.

At all times, they have to keep in mind that the sole purpose of providing samples must be health professionals' familiarisation with the product, not free promotion.

Pharmaceutical companies are allowed to organise scientific meetings or congresses and sponsor attendance by healthcare professionals at these events as long as they are of ethical content according to the industry self-regulation, rather than State legislation. The fundamental purpose of these programs should be to facilitate the constant learning of health professionals for the benefit of patients. These programs should not be used to influence or reward health professionals for prescriptions or recommendations of a particular pharmaceutical product.

No company can organise or sponsor events outside the country, unless it is appropriate and justified for logistical or security reasons. Events that include professionals from many countries are justified and allowed. Events abroad should be located in an appropriate place and should not include entertainment and leisure activities.

Pharmaceutical companies are not allowed to organise or sponsor cultural, sports or other non-scientific events in relation to scientific conferences. They cannot provide or pay for social, entertainment and leisure activities.

The provision of grants or donations to healthcare professionals or healthcare institutions is not regulated specifically for the pharmaceutical industry. The civil rules related to donation of goods would be applied.

In Ecuador, there are no restrictions for pharmaceutical companies to give rebates or discounts to health professionals or healthcare institutions.

Pharmaceutical companies can pay healthcare professionals for their services as long as a contract has been signed that specifies the following:

  • the nature of the services;
  • the legitimate need for the services; and
  • a reasonable remuneration that reflects the market value.

There are no prior authorisations or notifications provided in any normative established by the national competent authorities (the Agency for Health Regulation and Surveillance, or any other Health Authority).

In Ecuador, pharmaceutical companies are not required to disclose details of transfers of value to healthcare professionals or healthcare institutions.

In Ecuador, there is no obligation for the pharmaceutical companies to disclose the details of any transfer of value to health professionals or institutions.

The agencies responsible for regulating and controlling the advertising of non-prescription medications are the following:

  • Agency for Health Regulation;
  • Control and Surveillance;
  • the Ministry of Health;
  • the Superintendence of Market Power Control; and
  • the Ombudsman's Office.

Similarly, any ruling from these administrative authorities will be known and resolved in the administrative courts.

In Ecuador, processes can be initiated for deceptive advertising that occurs when advertising characteristics are not true or verifiable. Similarly, a complaint can be initiated if a prescription drug is advertised. These actions are initiated in the ARCSA, the Ministry of Health, before the Superintendence of Market Control and Power, or the Ombudsman's office.

The public bodies responsible for monitoring and sanctioning can impose fines ranging from ten unified basic salaries to a fine of the 10% of the annual turnover of the offending company. Similarly, regulatory bodies may request the forfeiture of the violating product or the temporary or final closure of a company that violates the regulation on advertising and prescriptions.

Any measure ruled by an administrative authority may or will be reviewed by the administrative courts if it is required. It is in the power of the courts to ratify or overrule what the administrative authorities dictate, this is the relationship that exists between these two.

The public administration, through Executive Decrees 522 and 1159, wanted pharmaceutical companies to market their medicines as generic once the invention patents have expired. The Competition Authority initiated an investigation of pharmaceutical companies for alleged breach of the provisions of the decrees. This was the beginning of one of the most important cases in recent years, after a year and a half of investigation it ruled in favour of the pharmaceutical companies. Since the Organic Health Law did not require that companies submit patents or their states before marketing a medicine, the provisions of the decrees were impossible to enforce. With the ruling in favour as a clear precedent, both decrees were repeal by the government and there is no need to mark medicines as generic once the patents have expired. 

Meythaler & Zambrano Abogados

Av. 6 de Diciembre 2816 y Paúl Rivet
Edif. Josueth González
10mo piso

+593 2 223 2720

+593 2 223 2720

info@lmzabogados.com www.lmzabogados.com
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Law and Practice

Authors



Meythaler & Zambrano Abogados is one of the most prestigious law firms in the Ecuadorian market. Founded in 1995, the firm specialises in national and international legal-counselling and litigation for international and domestic corporations. The firm's highly qualified team focusses on regulatory counsel (pharmaceutical, medical, food and cosmetic, in addition to agricultural sectors), intellectual property, competition and antitrust, arbitration and mediation, corporate and commercial affairs, dispute resolution, taxes, public procurement and public law. The firm has offices in Quito and Guayaquil that work across Ecuador, and belong to a wide network of correspondents throughout America, Europe and Asia. The firm is part of the International Bar Association (IBA), the International Trademark Association (INTA), the Intellectual Property Association (ASIPI) and the Ecuadorian Associations of Mediation and Taxation Law.

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