by Deborah Portilho and Ana Karina de Macedo Tito
The International Comparative Legal Guide to: Pharmaceutical Advertisement 2007. Global Legal Group. London, 2007, p. 55-62
1. General – Medicinal Products
1.1 What laws and codes of practice govern the advertising of medicinal products in your country?
The advertising of medicinal products in Brazil is monitored, at the government level, by the Brazilian National Health Surveillance Agency (ANVISA), which was created in 1999 (Law No. 9782/1999). In addition, the Brazilian Self-Regulation Advertising Council (CONAR) has established rules to prevent misleading or abusive advertising from causing injury to consumers or companies.
CONAR has a code, called the Brazilian Code of Self-Regulation in Advertising, which governs all aspects of advertising, including over-the-counter medicines.
In turn, ANVISA’s regulatory control is mainly centred on Board of Directors Resolution (RDC) No. 102/2000. The provisions and instructions defined therein provide details on what information should or should not be present in the advertising of these products.
Legal regulations are established by the 1988 Federal Constitution of Brazil (§ 4 of Art. 220). However, Law No. 6,360/1976, which precedes Brazil’s Constitution, had already dealt with this subject, and remains valid to-date, and all advertising in Brazil must comply with the provisions established therein. This Law merely states that the advertising of prescription medicines should be restricted to professionals qualified to prescribe or dispense medicines, and bars the inclusion of any indications that might generate misinterpretation, error or confusion regarding the characteristics of the product.
Under the terms set forth in the Brazilian Constitution, Law No. 9,294/1996 and Decree No. 2,018/1996 were introduced to regulate the advertising of tobacco products, alcoholic beverages, agrochemicals and medicines. Although specifically relating to advertising, this Law is more superficial when dealing with medicines, to the extent that the subject is treated with greater detail in the aforementioned Resolution.
In addition to these main directives, certain other ANVISA resolutions specifically refer to the advertising of medicinal products: Resolution RDC No. 83/2002, which establishes rules for advertising Acetylsalicylic Acid (Aspirin)-based medicines; Resolution RDC No. 197/2004, which defines the vehicles permitted for advertising medicines subject to special control, and Resolution RDC No. 199/2004, which establishes the way in which the prices of medicines must be advertised to the general public.
Of further note is the Consumer Protection and Defence Code (Law No. 8078 introduced in the year 1990) which bars misleading or abusive advertising, as defined therein.
1.2 How is “advertising” defined?
In Brazil, the definition of advertising used by government inspection and monitoring agencies is that set forth in Art. 2 of Resolution RDC No. 102/2000: ADVERT1SING/PUBLICITY: set of techniques used with the purpose of disclosing knowledge and/or promoting the adherence to principles; ideas or theories designed to exert influence over the public by way of actions aimed at promoting a certain medicine for commercial purposes.
Based on this definition, ANVISA does not differentiate advertising from publicity. Advertising is deemed to be any technique used to disclose medicines.
1.3 Must advertising be approved in advance by a regulatory or industry authority before use? If so, what is the procedure for approval? Even if there is no requirement for prior approval in all cases, can the authorities require this in some circumstances?
Although Art. 58 of Law No. 6,360/1976 provides that: advertising, under any form of disclosure and means of communication, of products governed by this Law, may only be carried out following authorization from the Ministry of Health, according to regulation to be implemented, this regulation has never been published. Furthermore, based on the 1988 Federal Constitution, the competent authority understands that this kind of approval would be unconstitutional because it would limit freedom of expression. So this section of the Law has never been implemented, either before or after the introduction of the 1988 Federal Constitution.
The only occasion in which ANVISA can require prior approval is in case of corrective statements, which can only be released after its approval. Other than that, effectively there are no legal provisions concerning prior approval for advertising by a governmental or other authority in Brazil.
1.4 If the authorities consider that an advertisement which has been issued is in breach of the law and/or code of practice, do they have powers to stop the further publication of that advertisement? Can they insist on the issue of a corrective statement? Are there any rights of appeal?
Irregular advertising is subject to prohibition (Law No. 6,437/1977, Art. 2, section IX) and suspension (Law No. 9,294/1996, Art. 9, section II) by ANVISA. The suspension and prohibition of advertising, besides other sanctions described in question 1.5 below, are provided for in health surveillance legislation and are enforced after an administrative procedure. However, when an irregularity is deemed to be of major risk to the population’s health, there is a provision in Law No. 9,782/1999, which created ANVISA, allowing that Agency, as a precautionary measure, to determine the immediate suspension of the publication, even before an administrative procedure begins. This is done by way of a Specific Resolution (RE) directed at the company.
In practice, at the end of this procedure, the penalty handed down in most cases is an advertising prohibition and a fine. Nevertheless, bearing in mind the long, drawn-out nature of legal procedures and the speed at which the publicity campaigns come and go, in most cases the advertisements are no longer being aired by the time a penalty is finally served.
The suspension provision set forth in Law No. 9,294/1996 provides that suspension may last up to thirty days and encompass all advertising related to the product, that is, not just the irregular ones.
Moreover, it is indeed possible for ANVISA to order the publication of a corrective statement to negate the distorted advertising or advertising presented in bad-faith (Law No. 9,294/1996, Art. 9, section III), that is to say, the obligation to publish a rectificatory message, provided in such terms in Law No. 6,437/1977, Art. 2, section XII.
Being the result of an administrative procedure, the enforcement of these sanctions is final at the administrative level, but companies are always entitled to take the matter to court.
1.5 What are the penalties for failing to comply with the rules governing the advertising of medicines? Who has responsibility for enforcement and how strictly are the rules enforced? Are there any important examples where action has been taken against pharmaceutical companies? To what extent may competitors take direct action through the courts?
The penalties for failing to comply with the rules governing the advertising of medicines are set forth in Law No. 6,437/1977 and Law No. 9,294/1996. They comprise: a warning; prohibition of advertising; suspension of advertising; suspension of the sale of the product; seizure of the product; a fine (approximately US$1,000 to US$750,000); obligation to disclose a corrective statement; and suspension of any other advertising of the product in the publicity disclosure vehicle, for a term of up to thirty days. All these sanctions may be applied cumulatively.
The enforcement of these sanctions falls under the responsibility of ANVISA, which is accountable for inspecting/monitoring pharmaceutical advertising.
After a lengthy period with almost no legal action in this sector, inspection and monitoring of advertisements effectively began with the creation of ANVISA in 1999, albeit by a sampling method, and whenever irregularities have been found, sanctions have often been applied in a strict manner. It is also worth mentioning that, as a rule, the sanctions ultimately amount to fines and prohibition of advertising.
As for competitors, they may report irregular advertising to ANVISA, to CONAR, or file a court action with a request for an injunction to stop the irregular advertisement. However, in the latter case an action can only be taken if the plaintiff proves to have a legitimate interest in the case.
1.6 What is the relationship between any self-regulatory process and the supervisory and enforcement function of the competent authorities? Can, and, in practice, do, the competent authorities investigate matters drawn to their attention that may constitute a breach of both the law and any relevant code and are already being assessed by any self- regulatory body? Do the authorities take up matters based on an adverse finding of any self-regulatory body?
In point of fact, there is currently no relationship to speak of between the regulatory agency (ANVISA) and the self-regulatory body (CONAR). However, attempts have been made by the two institutions to join forces. So far, a few actions were taken jointly in the years 2003 and 2004. In these actions, CONAR analysed commercials at the request of ANVISA, adopting the measures as provided for in its code.
Penalties served by the competent authority are independent from those applied by CONAR, and any action carried through by one of these bodies does not prevent the other from taking its own steps.
Even if advertising analyses performed by CONAR result in the suspension or change in the advertisement, the regulatory body may simultaneously or subsequently take its own action. One action does not prevent another, and ANVISA has a term of 5 years, counted as of publication of the advertisement, to file a suit to investigate the irregular promotion of medicines.
With regard to the possibility of ANVISA taking up matters based on adverse findings of CONAR, any person, company or even an anonymous party can file a report to ANVISA and the appropriate measures will be taken. Yet it is not common for CONAR to submit cases of irregular advertising for ANVISA to take the necessary action.
1.7 In addition to any action based specifically upon the rules relating to advertising, what actions, if any, can be taken on the basis of unfair competition? Who may bring such an action?
Even though there are no specific rules concerning unfair competition in advertising regulations for medicines, some of the norms concerning comparisons or statements in general can be utilized indirectly to resolve issues related to advertising.
In any case, ANVISA is unlikely to take action against an advertisement based on unfair competition, unless it poses a threat to the population’s health.
Likewise, CONAR is not likely to take any action on its own based on unfair competition. This should be done by the injured company, either taking the matter to CONAR or by means of filing a civil court action against the infringing party.
2. Providing Information Prior to Authorization of Medicinal Product
2.1 To what extent is it possible to make information available to health professionals about a medicine before that product is authorized? For example, may information on such medicines be discussed, or made available, at scientific meetings? Does it make a difference if the meeting is sponsored by the company responsible for the product?
The promotion and advertising of unregistered medicines, as well as of off-label indications and dosages is prohibited in Brazil. Even if such medicines are being examined by ANVISA for subsequent issuance of a registration, until they are authorized, and until such authorization has been published in the official press, the product is deemed to be unregistered, and therefore cannot be advertised, not even to health professionals.
Despite this clear restriction, “information” does not come under the definition of advertising. Any scientific information, be it that taken directly to the doctor’s office, or aired for debate at scientific events, is allowed, regardless of product approval by ANVISA.
Nevertheless, it is highly important that such material not be of an advertising nature, does not bear biased information and does not carry the products trade name. It must truly be scientific material: complete, balanced and impartial.
The same applies to events sponsored by the pharmaceutical industry. The subject of debate at scientific events must be of a scientific nature, and must not be transformed into product advertising.
Once the event’s function of enabling a scientific exchange of information has been distorted, the sponsor runs the risk that the event may be qualified as product publicity, and must then comply with all specific legislation.
2.2 May information on unauthorized medicines be published? If so, in what circumstances?
As mentioned above, scientific information is not characterized as advertising and is therefore allowed, regardless of product approval by ANVISA. If, however, the information published is of an advertising nature, it will be deemed to be advertising of unregistered products and, therefore, considered irregular.
2.3 Is it possible for companies to issue press releases about medicinal products which are not yet authorized? If so, what limitations apply?
Again, the rules are the same, with just one more proviso: since the material is printed by the company that is responsible for the product, the chances that ANVISA will consider it to be advertising, and thus digressing from that which is deemed to be scientific matter, are much higher. Accordingly, greater caution is needed in the preparation of such material. It is important to give due regard for balanced information, and when disclosing the benefits of the product, the risks must also be addressed, besides providing complete information without slogans or publicity appeal.
2.4 May such information be sent to health professionals by the company? If so, must the health professional request the information?
Yes, this type of information may be sent to health professionals. Moreover, there is no legal provision in Brazil requiring that such professionals must request this information to be sent. The restriction again lies in the kind of information. A scientific article, for example, can be sent to doctors and even to patients. However, if the information is deemed to be advertising and the product is not registered, it cannot be sent to anyone. It is crucial to review what differentiates information on medicines from advertising of medicines in the items above.
2.5 May information be sent to institutions to enable them to plan ahead in their budgets for products to be authorized in the future?
Information sent by the company that is responsible for the product must comply with the same rules when it is of an advertising nature. It is not ANVISA’s attribution to analyze information in cases where such information is not designed to advertise the product. It is crucial to bear in mind that if the information really has this characteristic, it is unlikely to become the subject of analysis by ANVISA.
3. Advertisements to Health Professionals
3.1 What information must appear in advertisements directed to health professionals?
Information required in the advertising of medicines is set forth in Resolution RDC No. 102/2000 and varies according to the classification of the drug. For the advertising of non-prescription drugs, the compulsory information comprises: trade name (brand of medicine); name of active substance; the product registration number issued by ANVISA; main contraindication and the warning “If symptoms persist, consult your doctor”.
For prescription drugs: trade name; name of active substance; registration number; indications; contraindications; care and warnings; dosage and classification of prescription and dispensation.
Besides this compulsory information, whenever the advertising makes technical statements concerning the drug or draws comparisons, such should be scientifically provable, and prescription drugs must carry a full bibliographic reference in the advertisement.
3.2 Is it a requirement that there be data from any or a particular number of “head to head” clinical trials before comparative claims are made?
Even when comparative claims in drug advertising are indirect, the rule is that they must be based on information proven by clinical trials disclosed in indexed publications. Furthermore, the general requirement that any statement contained in drug advertising must be scientifically provable also applies to comparisons.
In currently valid regulations, there are no restrictions on the type of clinical study or database in which such publications must be indexed.
3.3 What rules govern comparator advertisements? Is it possible to use another company’s brand name as part of that comparison? Would it be possible to refer to a competitor’s product which had not yet been authorised in your country?
Apart from the restriction referred to in question 3.2, comparator advertisements are not specifically addressed by Brazilian regulations.
There are no provisions concerning the possibility of, or prohibition on, using a third party’s brand name in product advertising. This often occurs in advertisements for generic drugs and the reference product, in which the name of the latter is mentioned, generally for price comparison purposes. When the information is misleading, or when the manner in which the information is presented is likely to lead consumers to believe that a “similar” product (one that is not registered as a generic and has not been submitted to bioequivalence tests) may be interchangeable with the reference drug, the advertisement will be deemed irregular.
With regard to comparisons with medicines that are not registered in Brazil, the general rule governing comparisons applies, that is, they must be based on scientific information and be provable.
3.4 What rules govern the distribution of scientific papers and/or proceedings of congresses to doctors?
No rules have been established on the distribution of scientific papers to doctors. As stated previously, papers are not considered to be drug advertising and therefore cannot be the subject matter of regulations.
Attention should be drawn to the fact that scientific papers are not of an advertising nature and therefore cannot bear slogans or publicity appeal. If such characteristics are present, the papers will be deemed to be publicity materials and must then bear the information cited in question 3.1, according to their prescription and dispensation classification, and also comply with the restrictions relating to registration and to target public.
3.5 Are “teaser” advertisements permitted, which alert a reader to the fact that information on something new will follow (without specifying the nature of what will follow)?
Once again, this theme is not specifically addressed by Brazilian legislation. However, under Art. 9 of Resolution RDC No. 102/2000, any kind of drug advertising, publicity or promotion aimed at the general public must be carried out in such a way that clearly shows the promotional nature of the message and must comply with the legal provisions described in the technical instructions of the aforementioned Resolution. Furthermore, communication directed towards health care professionals, aired in mass communication media, verbal or not, is deemed to be advertising, and accordingly is subject to the legal provisions set forth in the aforementioned Resolution.
4. Financial Incentives
4.1 It is possible to provide health professionals with samples of products? If so, what restrictions apply?
Yes. It is possible to provide free samples of products, with due regard to the following rules: the packaging must contain at least 50% of the contents of the original approved by ANVISA; it must be exclusively destined for professionals who are qualified to prescribe or dispense drugs; it must contain the batch number and the wording: “FREE SAMPLE”, and be displayed in letters that are no less than 70% of the size of the brand name or, in the absence thereof, the name of the active ingredient (INN). Further, the company must file updated records to ANVISA relating to the distribution of such free samples for a minimum period of two years.
Drugs containing substances subject to special control must comply with specific regulations, namely Ordinance No. 344/1998, which only allows the distribution of free samples of drugs included in lists C1 and C4 of the regulation, provided that they are distributed in their original packaging and sent exclusively to medical professionals, who will sign the distribution receipt issued by the manufacturer.
4.2 Is it possible to give gifts or donations of money to medical practitioners? If so, what restrictions apply?
It is not possible to offer gifts or donations of money to health care professionals in general. This rule is not made precisely clear in the law, because on one hand, the caput of Art. 19 of Resolution RDC
No. 102/2000 prohibits such practice, whereas on the other hand the sole paragraph of the same article allows it, provided that these gifts or money donations are not requested or accepted on the condition of sale, prescription or dispensation of drugs. Linking the benefit to the prescription, sale or dispensation cannot be made under any circumstances.
4.3 Is it possible to give gifts or donations of money to institutions such as hospitals? Is it possible to donate equipment, or to fund the cost of medical or technical services (such as the cost of a nurse, or the cost of laboratory analyses)? If so, what restrictions would apply?
There are no regulations on such practice. However, if the donations or funds are contingent on the prescription of medicines, they may be questioned by the regulatory agency, by means of an administrative procedure.
4.4 Is it possible to provide medical or educational goods and services to doctors that could lead to changes in prescribing patterns? For example, would there be any objection to the provision of such goods or services if they could lead either to the expansion of the market for or an increased market share for the products of the provider of the goods or services?
If the benefits are conditioned to altering the prescription patterns, the practice will be deemed to be irregular under the provision mentioned in question 4.2. Furthermore, the Code of Ethics issued by the Federal Board of Medicine bars the procurement of advantages through the commercialization of medicines, the purchase of which stems from the direct influence of the health professional’s activity. In other words, if the alteration in prescription patterns is a consequence of the benefit received by the doctors, it will be irregular in the eyes of the Board of Medicine and of ANVISA.
4.5 Do the rules on advertising and inducements permit the offer of a volume related discount to institutions purchasing medicinal products? If so, what types of arrangements are permitted?
There are no rules in health legislation that limit the discount volume offered by companies to institutions. But in terms of the drug advertising material, even if only concerning the product purchase conditions, the same rules for any drug advertising apply.
Directives for advertising discounts to the general public are set forth in Resolution RDC No. 199/2004.
4.6 Is it possible to offer to provide, or to pay for, additional medical or technical services or equipment where this is contingent on the purchase of medicinal products? If so, what conditions would need to be observed?
As this concerns the acquisition of medicines by institutions, there are no regulations on this practice.
4.7 Is it possible to offer a refund scheme if the product does not work? If so, what conditions would need to be observed? Does it make a difference whether the product is a prescription-only medicine, or an over-the-counter medicine?
There is no provision for this kind of scheme. It is a current practice in Brazil for prescription-only medicines, and no such cases have been the subject of an administrative procedure. However, the product category needs to be observed for over-the-counter medicine. If such medicine is for symptomatic treatment, it is not possible to establish criteria for a logical refund system for cases in which the medicine is not effective.
4.8 May pharmaceutical companies sponsor continuing medical education? If so, what rules apply?
Under current regulations, there are no specific restrictions on sponsoring continuing medical education by pharmaceutical companies. In case educational material includes publicity, restrictions that may apply are those relating to drug advertising.
5 Hospitality and Related Payments
5.1 What rules govern the offering of hospitality to health professionals? Does it make a difference if the hospitality offered to those health professionals will take place in another country?
Any payments to doctors by the pharmaceutical industry, whether or not it relates to the participation in scientific events in Brazil or abroad, must comply with the rule that such payment is not contingent on the prescription of a particular medicine.
When the sponsored doctor is a lecturer at the event, the following rules also apply: the partial or full sponsorship must be discriminated in all disclosure documents or materials resulting from the respective event; it must not be contingent on the promotion of any kind of medicine or institution, and this must be clearly stated on said documents; and any industry-sponsored lecturer must divulge the sponsor’s name on the events disclosure material.
Additionally, ANVISA’s directives include the following: lecturers at any scientific session that maintain any form of relationship with the pharmaceutical laboratories present at the event must inform the potential conflict of interests to the event organizers in the events official programme, in the annals, and must also inform this fact at the beginning of his/her lecture, as per the Code of Ethics issued by the Federal Board of Medicine.
5.2 Is it possible to pay for a doctor in connection with attending a scientific meeting? If so, what may be paid for? Is it possible to pay for his expenses (travel, accommodation, enrolment fees)? Is it possible to pay him for his time?
Any form of sponsorship for doctors is subject to the restrictions relating to gifts, monetary awards or cash. In other words, the sponsorship cannot be contingent on the doctor’s prescription of certain drugs. In addition, if the doctor is a lecturer, the sponsorship cannot be contingent on product promotion, and the potential conflict of interest must be declared during the presentation and in the event materials, as stated in question 5.1.
5.3 To what extent will a pharmaceutical company be held responsible by the regulatory authorities for the contents of and the hospitality arrangements for scientific meetings, either meetings directly sponsored or organized by the company or independent meetings in respect of which a pharmaceutical company may provide sponsorship to individual doctors to attend?
Since there are no specific rules regarding the sponsorship of doctors at congresses, if it is found that the benefits provided to such professionals are linked to the promotion or prescription of certain drugs, then the responsibility will be the same as for other infractions established in Brazilian regulations. The company and all those involved in the infraction, including the doctor, may be held liable and penalized, as stated in question 1.5.
5.4 Is it possible to pay doctors to provide expert services (e.g. participating in focus groups)? If so, what restrictions apply?
Drug advertising regulations do not specifically address each kind of sponsorship that may be afforded to doctors, nor do they establish what the benefit may be in exchange for. The rulings are clear in terms of the following aspects: benefits may not be offered in exchange for medical prescriptions or, at congresses, be linked to the advertising of medicines by the sponsored professional. Accordingly, only this restriction should be taken into account for specific cases of payments to doctors to provide expert services.
5.5 Is it possible to pay doctors to take part in post marketing surveillance studies? What rules govern such studies?
Health legislation does not establish rules for a doctor’s participation in studies. However, the rulings established in the Code of Ethics issued by the Federal Board of Medicine must be observed, and payments cannot be linked to the prescription of the drug in question.
5.6 Is it possible to pay doctors to take part in market research involving promotional materials?
Yes, this is possible provided that the payment is not linked to prescribing the medicine. Resolution RDC No. 102/2000 provides that when the name and/or image of the professional is specifically cited as support for the benefits announced in the medicine, the publicity message must necessarily carry the name of the intervening professional and his/her registration number at the respective board. However, the Federal Board of Medicine’s Code of Ethics States that his/her participation in the disclosure of medical matters, in any mass communication vehicle, must be solely to educate and provide explanations to the general public.
6. Advertising to the General Public
6.1 Is it possible to advertise non-prescription medicines to the general public? If so, what restrictions apply?
Yes. The disclosure of non-prescription medicines to the general public is allowed, and must compulsorily include the following information: trade name (medicine brand); name of the active substance; the product registration number issued by ANVISA; main contraindication and the warning “If symptoms persist, consult your doctor”.
Besides the obligatory information, the advertisement is barred from inducing the indiscriminate use of the drug; disclosing the drug for indications that differ from those indications registered; causing fear or anguish by suggesting that a person’s health may be affected by not using the medicine; including messages targeting children or adolescents, among other prohibitions set forth in Resolution RDC No. 102/00 and in other norms applicable to the pharmaceutical advertising.
6.2 Is it possible to advertise prescription-only medicines to the general public? If so, what restrictions apply?
No. Under Law No. 6,360/1976 and Law No. 9,294/1996, the advertising of prescription-only medicines must be restricted to professionals who are qualified to prescribe or dispense medicines. Under no circumstances is it possible to advertise prescription-only medicines to the general public.
6.3 If it is not possible to advertise prescription only medicines to the general public, are disease awareness campaigns permitted, encouraging those with a particular medical condition to consult their doctor, but mentioning no medicines? What restrictions apply?
There is currently no specific provision regarding such campaigns. Nevertheless, this kind of advertising is often used to make the general public aware of new treatments, directing people to seek further information from their doctor. If the advertisement is made in such a way that, even without a specific mention of the mark, consumers may identify the product, ANVISA may commence proceedings against the company for advertising prescription-only medicines to the public at large.
However, if the material only speaks of the disease and the importance of seeking further guidance from a doctor, without suggesting that medical treatment is available, or attributing any specific characteristic to the medicine in the advertisement, it is unlikely that ANVISA will contest it.
6.4 Is it possible to issue press releases concerning prescription only medicines to non-scientific journals? If so, what conditions apply?
Whether or not it is possible to issue press releases concerning prescription-only medicines will depend on the way the information is presented, as it will reach the general public. If the information is of a publicity nature and only provides awareness of the benefits of the product, without speaking of its risks and limitations, it will be deemed as advertising of a prescription-only medicine and, therefore, subject to questioning by ANVISA.
6.5 What restrictions apply to describing products and research initiatives as background information in corporate brochures/Annual Reports?
Brochures and Annual Reports can only highlight information concerning research initiatives or the description of products in an institutional manner, so as not to characterize advertising. If an advertisement is presented in corporate brochures or in Annual Reports, all the restrictions prescribed in the regulations must be observed, e.g., prior authorization of the product; restriction on the target public according to the drug classification; and compulsory information.
6.6 What, if any, rules apply to meetings with and funding of patient support groups, including any transparency requirement as regards the recording of donations and other support in corporate reports?
There is no provision in the specific rulings on pharmaceutical advertising for this kind of event.
7. The Internet
7.1 How is Internet advertising regulated? What rules apply? How successfully has this been controlled?
Regulations applicable to other Communications media equally apply to pharmaceutical advertising on the internet. However, since the internet is accessible to all, access to the disclosure of prescription medicines on the internet should be restricted to professionals qualified to prescribe or dispense medicines. Accordingly, companies wishing to use this vehicle should create a form of user registration so as to enable access only by such professionals.
Bearing in mind the speed with which information changes on the internet, coupled with the lack of specific legislation to hold offenders who use this medium to account, internet inspection/monitoring is somewhat prejudiced. Nevertheless, the inspection authority in Brazil has been very successful, especially concerning its search for irregular products, which are not even authorized for commercialization in the country.
With regard to pharmaceutical industries that advertise lawful products, inspection and monitoring is made basically by way of denunciations and the examination of addresses which appear in other vehicles analyzed. In such cases, the main examination is in respect of the presence of compulsory information and whether or not access to the advertising of prescription medicines is restricted.
7.2 What, if any, level of website security is required to ensure that members of the general public do not have access to sites intended for health professionals?
There is currently no provision concerning the regulation of the level of access security. The ruling is: when the medicine is prescription only, advertising these products on the internet is only allowed if accessed exclusively by professionals qualified to prescribe or dispense medicines. Therefore, provided a control is in place, such as user registration, for example, the requirement will be considered fulfilled.
8. Medical Devices
8.1 What laws and codes of practice govern the advertising of medical devices in your country?
There is no specific regulation for the advertising of medical devices, but Law No. 6,360/1976, which governs health surveillance to which medicines are subject, also encompasses correlated products, cosmetics, sanitary and other products, and is therefore applicable to the advertising of health care products (formerly called correlated products).
Under Art. 59 of the aforementioned Law, advertising health care products cannot bear images or statements that might lead to misinterpretation, error or confusion, particularly concerning the nature, origin and quality of the product, nor must they ascribe the product purposes or characteristics that differ from those that they truly possess. Consequently, the advertising of medical devices must observe the following pre-requisites: only disclose products that have been authorized by ANVISA and not claim that they have properties different to those registered.
The requirement of limiting the information included in the advertising material to that registered at ANVISA is also prescribed in item 2, part 4, annex, of Resolution RDC No. 185/2001.
8.2 Are there any restrictions on payments or hospitality offered to doctors in connection with the promotion of a medical device?
To date, there are no regulations on this matter.
9. Developments in Pharmaceutical
9.1 What have been the significant developments in relation to the rules relating to pharmaceutical advertising in the last year?
In November 2005, ANVISA published Public Consultation No. 84/20005, with the proposed new wording for pharmaceutical advertising regulations that have been in force since the year 2000. Since this Public Consultation was published, various debates have been organized with interested entities from the sector that is regulated, the public health sector, consumer defense organizations and academy members, for contributions to the final text. However, so far the necessary Public Hearing has not yet been held to finalize the text and publish the new regulations.
Changes in the text published originally for the Public Consultation are already quite substantial and are based on contributions sent during the validity of the Public Consultation. In our opinion, contributions likely to have the biggest impact are:
• the form of presenting the required information – minimum font size, in addition to the balance between information relating to risk with the benefits of the medicine;
• increased number of obligatory warnings, and
• greater objectivity in detailing that which is barred from advertising.
9.2 Are any significant developments in the field of pharmaceutical advertising expected in the next year?
It is expected that the regulations mentioned in question 9.1 will be published this year, to the extent that in 2008 the advertising of medicines should be governed by the new regulations, in addition to the currently valid laws.
9.3 Are there any general practice or enforcement trends that have become apparent in this jurisdiction over the last year or so?
As stated in question 1.5, companies in breach of the laws on pharmaceutical advertising, among other penalties, are obliged to publish a corrective statement. So far, this penalty has only been enforced a few times due to the lack of regulations on the way in which such message must be communicated, hampering enforcement by ANVISA at the execution procedures.
It so happens that in 2005, with the publication of Public Consultation No. 84/2005, ANVISA established the criteria for enforcing the penalty concerning the publication of a corrective statement, as well as the way in which the company must fulfill such penalty.
It is our understanding that the publication of corrective statements will tend to become more and more frequent in cases considered serious by ANVISA, because the effectiveness of such a sanction is much greater than enforcing a fine or ordering the belated suspension of the advertising.
