Contributed By Meythaler & Zambrano
The laws and codes that regulate the advertising of medicines in Ecuador are extensive. The main regulatory bodies are:
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. Dealing with self-regulation and being dependent on an association applies across the industry, particularly to companies that are part of that association.
These instruments have taken on great importance for associations, their members and for the state, which 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 in the health system, be these officials, patients or associations. It is for this reason that several of the concepts of self-regulation and Codes of Conduct are regulated by the Health Authority.
Regarding the legal value of the rules imposed by self-regulation, in the first instance, they are part of internal regulation and norms of ethics and anti-corruption (compliance standards). Many of the principles established in self-regulation were in fact inserted in the Organic Code of Health to be discussed in the national assembly. Unfortunately, the aforementioned Code was totally vetoed by the president of the republic and consequently, various rules on promotion and advertising are still part of self-regulation.
Pharmaceutical advertising is defined as any form of offer – written, electronic, visual or other – 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 Authority, and it is characterised by delivering commercial information on a specific medicine that must correspond to its true nature, composition, quality or origin, etc, in order to prevent the consumer from purchasing it in error.
In Ecuador, the advertising of medicines subject to prescription is prohibited.
The difference between advertising and information lies in its purpose. Advertising has an economic purpose, seeking an increase in sales, and informing on the benefits of a particular medicine. Information, however, is training that is not tied to a specific product or brand. Patient programmes are not part of an advertising campaign, as long as they do not seek to profit in any way from the same and do not tie or relate a brand to the initiative.
One important clarification to note is that, in relation to leaflets for patients, these are part of the labelling of medicine. They are subject to the prior approval and control of the Health Authority and are not considered to be part of advertising.
Ministerial Agreement 179 regulates the promotion of medicines in general. Article 9 authorises the advertising of medicines through the press, for those that are classified as OTC products, processed natural products for medicinal use, homeopathic medicines, and 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, after the Communication Law came into force, this requirement was abolished. The new Communication Law that facilitated the advertising of OTC medicines through the press was published on 20 February 2019.
The only pharmaceutical products that can be advertised through the press are OTC medications, ie, those that are not subject to medical prescription.
Advertising, promotion, endorsement and sponsorship of medicines in general, processed natural products for medicinal use and homeopathic products containing cannabinoids with THC concentrations less than, equal to or greater than 1%, will be subject to the provisions of Ministerial Agreement No 179 or the regulations that replace it.
Comparative advertising is allowed as long as it falls within the following parameters:
Legal rules such as codes of conduct establish that, if comparative advertising is used, 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 Ecuador is allowed only if it is for training purposes. This type of activity cannot be directed towards the general public. It must be restricted to health professionals, the scientific community and other related parties. 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 the marketing of which has not been authorised by a competent Ecuadorian 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 in sharing such information is academic. The information must be clear and related to the conference being held.
At this type of event, there may be no reference to trade names or specific brands of drug as this could be construed 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, ie, those that have an approved sanitary registration. 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 mention 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:
However, each case will be analysed and a way to accelerate the authorisation process in the market by the Health Authority will be sought.
Compassionate use is unregulated in local legislation. Regarding early access to a drug, it is understood that this 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 the purposes of human clinical research; in the case of hard-to-access drugs; for the supply of the public sector through international organisations; and 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 or establishments as beneficiaries.
As a consequence of the above, there is no express rule that allows the availability of compassionate-use programmes or other forms of early access to be published.
The prohibitions of public advertising in general are prescribed in AM 179. The prohibitions are comprehensive and include the following:
During 2021, specific regulations were issued for products containing cannabis; however, these products remain subject to the general rules and may be advertised only if they are registered as OTC products.
In relation to medical devices and biochemical reagents for the detection of COVID-19, the Health Authority has decided that in no case will these fall into an OTC category, and consequently, they cannot be advertised.
The advertising of OTC medicines to the public must have complete, suitable, supported, current and clear information, in Spanish.
The advertising of OTC medicines must contain the following information:
In addition, the information that reaches consumers cannot be misleading.
The Patient Organisation is independent and is not conditioned in any way by the other health agents. In this sense, any type of programme or benefit to the Patient Organisation must be transparent through the competent authority and before the same industry that self-regulates. In this sense, the multinational pharmaceutical industry has assumed self-regulation compliance rules in an organised way, according to the International Federation of Pharmaceutical Manufacturers and Associations (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, it is prohibited to:
In 2021, a reform to the Organic Criminal Code came into force, according to which acts of corruption in the private sector are criminalised. In accordance with this reform, the director, general manager, administrator, main executive, shareholders, partners, legal representatives, attorneys-in-fact, advisers, auditors, sponsoring lawyers or any employee who holds a management position in a private legal entity, non-profit organisation, the government, an association, a foundation or committee who intentionally accepts, receives or requests donations, gifts, presents, promises, rights, fees, contributions, rents, interests, advantages, salaries, gratuities, immaterial benefits or undue economic benefits or other material good, and who omits or commits an act that favours themselves or a third party, in the course of economic, financial or commercial activities, will be punished with imprisonment from five to seven years, and a fine of 500 to 1,000 unified basic salaries of the workers in general.
All advertising directed at healthcare professionals must contain the therapeutic indications or uses of the medicine, and this must be identical to the information provided to the competent authority to obtain the sanitary registration.
Confusing language that may cause misinterpretation cannot be used, nor expressions that cause fear or distress, or suggest that health may be affected by not using the medication. Furthermore, the advertised product may not be compared offensively 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 a place in 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 was used to obtain the sanitary registration.
Informally, medical science liaisons (MSLs) 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 prior to carrying out advertising for medicines. However, currently and since the Communication Law came into force, the requirement to obtain this authorisation has been abolished. The new Communication Law, which facilitates the advertising of OTC 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 pharmaceutical sciences. They must also wear the corresponding identification during any medical visit.
The Ministry of Health no longer has a record of the sales representatives in the pharmaceutical industry, so this matter is now the responsibility of each company.
No specific rules apply to advertising medicinal products on the internet but these 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 is excluded from the scope of regulation and administrative control.
Promotion refers to all the informative and persuasive activities deployed by drug manufacturers and distributors, and directed at prescribers with the aim of inducing prescription, including on a website.
Activities to promote medicines digitally must be carried out in compliance with the following legal requirements:
There is no rule that requires access restrictions to be placed on these websites. However, it is recommended that measures be taken, such as requiring the user to enter a username and password, to ensure that the person accessing the website is a health professional.
Companies are not allowed to provide disease awareness information and/or materials to patients online.
The COVID-19 pandemic has strengthened the use of technology for all purposes, including scientific, medical and educational meetings; but unfortunately, in Ecuador, there is no specific regulation that provides the requirements and conditions that must be met from a health point of view. For this reason, in the case of events organised virtually, companies must abide only by the rules contained in the codes of conduct.
Leaving aside the health field, online conferences must be governed by two relevant laws: the Organic Law of Communication published on 25 June 2013 and the Law of Electronic Commerce Signatures and Data Messages issued on 17 April 2002.
According to the first, it is established that the law does not regulate the information or opinion that is issued in a personal way through the internet; it is for this reason that, in general, the meetings that take place online are not considered as local events subject to the regulations of Ecuador.
The foregoing may change only if the call and the development of the meeting specify that it is a conference exclusively for health professionals living in Ecuador. In this case, local laws will apply, mainly with regard to promotion, advertising, use of materials, transfer of information related to current health authorisations, etc, which will be directly linked to the obligations of the Health Register holder.
Although what is mentioned in the two previous paragraphs applies to the determination of the local laws that must be complied with, compliance with the ethical and conduct standards is not altered by the mechanism used to conduct the meeting.
Electronic Commerce Law
Regarding the invitation, access to the conference and its recordings, the provisions of the Electronic Commerce Law must be taken into account, according to which, for the elaboration, transfer or use of databases, obtained directly or indirectly from the use or transmission of data messages, the express consent of the owner of these will be required. The collection and use of personal data must comply with the rights of privacy, intimacy and confidentiality guaranteed by the constitution of the republic and this law, which may be used or transferred only with the authorisation of the owner or by order of the competent authority.
It is strictly forbidden to advertise/promote pharmaceutical products to healthcare professionals who work in the public sector or public healthcare organisations.
In 2021, a reform to the Organic Criminal Code came into force, according to which, acts of corruption in the private sector are criminalised. In accordance with this reform, the director, general manager, administrator, main executive, shareholders, partners, legal representatives, attorneys-in-fact, advisers, auditors, sponsoring lawyers or any employee who holds a management position in a private legal entity, non-profit organisation, the government, an association, a foundation or committee who intentionally accepts, receives or requests donations, gifts, presents, promises, rights, fees, contributions, rents, interests, advantages, salaries, gratuities, immaterial benefits or undue economic benefits or other material good, and who omits or commits an act that favours themselves or a third party, in the course of economic, financial or commercial activities, will be punished with imprisonment from five to seven years, and a fine of 500 to 1,000 unified basic salaries of the workers in general.
Likewise, if any of the people referred to in the previous paragraph receive or accept improper economic benefits to boost one pharmaceutical company over another, they can be sentenced to up to seven years in prison.
The current Regulations for Publicity and Promotion of Medicines, Processed Natural Products for Medicinal Use, Homeopathic Medicines and Medical Devices, which regulate the subject, do not prohibit offering benefits or other inducements to healthcare professionals or organisations, as long as they are justified.
The latest reform established in the Code of Conduct of the pharmaceutical industry, prohibits all kinds of personal gifts.
It is also very important to consider the new crime of corruption in the private sector.
The offering of gifts or other items is not regulated by the state. However, the self-regulation of the pharmaceutical industry states the following:
All gifts have restrictions on value, which must be modest and adequate.
Samples provided to healthcare professionals by pharmaceutical companies are subject to certain limitations, such as:
At all times, pharmaceutical companies 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's self-regulation (rather than state legislation). The fundamental purpose of these programmes should be to facilitate the constant learning of health professionals for the benefit of patients. These programmes 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 this 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 or 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 on pharmaceutical companies giving 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:
No prior authorisations or notifications are required by the national competent authorities (ie, 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 pharmaceutical companies to disclose the details of any transfer of value to healthcare professionals or healthcare institutions.
The agencies responsible for regulating and controlling the advertising of non-prescription medications are the following:
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 by 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 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 be reviewed by the administrative courts if this is required. It is in the power of the courts to ratify or overrule what the administrative authorities dictate, as this is the relationship that exists between the courts and the authorities.
The public administration, through Executive Decrees 522 and 1159, required pharmaceutical companies to market their medicines as generic once the invention patents had 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 in which, after a year and a half of investigation, the authority 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 of the pharmaceutical companies as a clear precedent, both decrees were repealed by the government and there is now no need to mark medicines as generic once the patents have expired.