Summarise the rules relating to advertising and promotion of medicinal products and medical devices, explaining when the provision of information will be treated as promotional. Do special rules apply to online advertising?
The main rules governing the marketing, advertising and promotion of medicinal products are:
- Federal Law No. 9,294/1996, which regulates the advertising of drugs;
- RDC No. 96/2008 of the National Public Health Agency (ANVISA) (amended by ANVISA’s RDC No. 23/2009), which regulates the advertising and promotional practices of prescription drugs and over-the-counter drugs;
- ANVISA’s Normative Ruling No. 5/2009, which provides further clarification on ANVISA’s RDC No. 96/2008;
- Law No. 8,078/1990, which contains general provisions on the advertising of products in general; and
- the Advertising Self-Regulation Code, which regulates ethical rules related to advertisements and defines rules applicable to over-the-counter drugs. It is enforced by the Advertising Self-Regulation Council and was adopted in 1978.
Codes of conduct from trade associations, such as the Association of Research Based Pharmaceutical Industries and the Brazilian Association of High Technology Industrial Healthcare Products (ABIMED), also play a relevant role in the absence of regulation for some specific issues.
ANVISA’s RDC No. 96/2008 provides that advertising is a collection of techniques aiming to disseminate knowledge; make a certain product or brand better known or prestigious; exert influence over the public; or induce prescription, dispensation, acquisition and use of medication (article 2°). In other words, in the case of medicinal products, ANVISA may consider certain material as promotional whenever the product or treatment is mentioned (indirect promotion). On the other hand, materials with an educational or scientific aspect that only aim to inform about illness, research, etc (disease awareness), are not considered promotional.
If the general rules in relation to medicinal products advertising are complied with (fairness, balanced information, mandatory disclaimers, etc), companies are free to advertise on the internet. However, ANVISA’s RDC No. 96/2008 provides specific rules on internet advertising: companies cannot advertise or publish promotional materials in relation to prescription products or such promotion can only be accessible to professionals qualified to prescribe or distribute medicines.Inducement
What regulations exist to discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medicinal product or medical device?
Along with the codes of conduct from trade associations, ANVISA’s RDC No. 96/2008 prohibits any offer, promise or actual sponsorship of events (medical or health congresses, symposia, conferences and meetings) linked to the prescription, use, promotion, recommendation, suggestion or endorsement of a medicinal product.
ABIMED, one of the leading associations for medical devices manufacturers, provides in its code of conduct that: ‘Member Companies shall not directly sponsor the participation of healthcare professionals in third party events . . . . Notwithstanding, Member Companies can provide an educational subsidy in favour of a health organisation responsible for a third-party event or non-profit health organisation, so it can partially or completely sponsor the participation of healthcare professionals in a third-party event’ (item 5.1.3).
In addition, in Brazil, many of the healthcare professionals who work in the private sector are also public employees (working in the Unified Health System or as scholars at public universities, for example). Thus, they are also subject to Brazilian anti-corruption laws and the rules of their entities.Reporting transfers of value
What requirements apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices?
In Brazil, only the state of Minas Gerais has implemented rules regarding details of transfers of value to healthcare professionals (such as the American Sunshine Act). In accordance with Minas Gerais’s State Laws Nos. 22,440/2016 and 22,921/2018, healthcare companies (medicinal products and medical devices) must report the following to the Minas Gerais Health Secretariat: any relationships with healthcare professionals enrolled in Minas Gerais professional councils that constitute a potential conflict of interest; and sponsorships granted for scientific events held in the Minas Gerais.
Enforcement of advertising rulesEnforcers
Describe the bodies involved in monitoring and ensuring compliance with advertising controls for medicinal products and medical devices, distinguishing between any self-regulatory framework and control by the authorities.
The National Public Health Agency is the authority responsible for monitoring and ensuring compliance of advertising and marketing activities related to medicinal products and medical devices in respect of health. From the consumer perspective, authorities such as PROCON (with offices in all 26 states and the Federal District) may also work to enforce the legal and regulatory provisions. Self-regulatory entities (such as trade associations and the Advertising Self-Regulation Council (CONAR)) also monitor and ensure compliance according to their rules.Sanctions
What are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?
Federal Law No. 6,347/1977 establishes penalties for failing to comply with the rules governing the advertising of medicinal products and medical devices, which include warnings, suspension of sales, prohibition of advertising and corrective statements. They can be also accompanied by a fine, the value of which depends on the severity of the failure. Law No. 8,078/90 also provides similar penalties. Fines may reach millions of reais.
Infringers may also be concurrently subject to administrative procedures and penalties established by CONAR (in the case of over-the-counter drugs, suspension or alteration of the advertising action and warnings) and by trade associations.
Pricing and reimbursementPricing
What are the controls imposed on pricing of medicines and medical devices and reimbursement by national social security systems that are applicable to manufacturers, distributors and pharmacists?
The Pharmaceutical Market Regulation Chamber defines the price cap for most medicinal products after the marketing authorisation is granted by the National Public Health Agency (ANVISA). Some categories of medicinal products are exempt from price control under the assumption that the competition is enough to regulate the price (eg, dynamised medicinal products, compounding products, simplified notification medicinal products and herbal products)
Certain medicinal products must be sold under a maximum selling price to the government, which corresponds to the price cap minus a mandatory discount. This discount is updated from time to time and is a percentage of the total price, imposed on either the holder of the market authorisation or its commercial partners.
According to ANVISA’s RDC No. 185/2006, an economic report should be filed within the marketing authorisation application or the request for renewal for implants; however, it is only for monitoring purposes.
Despite universal access to the public healthcare system with full and free access to the population, it does not mean access to all kinds of treatments. There are several medicinal products and treatments that the Unified Health System (SUS) does not provide.
Federal Law No. 12,401/2011, which amended Federal Law No. 8,080/1990, updated the legal landscape and rationale to incorporate other lists involving specialised and strategic treatments within the SUS’s lists of mandatorily available treatments. It also created the National Committee for Technologies Incorporation (CONITEC) to perform health technology appraisal (HTA).
CONITEC is responsible for advising the Ministry of Health on the incorporation or disinvestment of health technologies into the SUS and development of clinical guidelines. It receives studies submitted by applicants and, after analysing HTA aspects, takes a position on inclusion or exclusion of health technologies.
HTA is a continuous process of analysing and summarising the potential health benefits and the economic and social consequences inherent in employing certain technologies, while considering the following aspects: safety, accuracy, efficacy, effectiveness, costs, cost effectiveness, aspects of equity, and the ethical and cultural and environmental impacts involved in their use.
However, the existing HTA route has some pitfalls and is often a barrier to citizens’ access to healthcare. HTA inadequacies have been considered a key factor in causing patients to seek court orders against the government to provide them with treatments not listed by the SUS. This litigation trend is widely discussed in Brazil, as it often opposes the individual constitutional right to healthcare against public expenditure and sanitary concerns.
Sale and supplyRegulation
Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?
The prescription of medicinal products by health professionals (physicians, pharmacists, nutritionists and dentists) is regulated by the federal council of each professional class and by the National Public Health Agency (ANVISA). Dispensing is regulated by Federal Laws Nos. 5,991/1973 and 13,021/2014. Under the Ministry of Health’s Ordinance No. 344/1998, however, prescription of certain controlled pharmaceuticals requires official medical prescription forms.
Some medicinal products, such as opioids, narcotics and psychotropic drugs, must be prescribed by a physician.
Under the public system, physicians must prescribe pharmaceuticals by the active pharmaceutical ingredient (API), while in the private system, physicians are free to determine if the prescription should be by the API or by the branded name of the product. Reference products and branded generics can be replaced for a generic, and vice versa, by the dispensing professional.
In the public system, the prescription and dispensing of pharmaceutical products supplied by the Unified Health System will be carried out in accordance with the Clinical Protocol and Therapeutic Directive for the corresponding illness or in specific official lists approved by the Ministry of Health.
For control of public expenditure on public health, pharmaceuticals and medical devices are acquired by the government via public procurement.
In the private market, the pharmaceuticals and treatments covered by private healthcare and insurance plans are defined in the agreement and on a list defined by the National Supplementary Health Agency.Online supply
What laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?
Online sales of medicinal products are subject to restrictions under Brazilian regulation. Sales must be made through electronic websites owned by pharmacies and drugstores duly licensed by public health authorities, according to ANVISA’s RDC No. 44/2009. In addition, medicinal products subject to special control cannot be sold online.
The legislation does not prevent online sales of medical devices, provided that the seller is a Brazilian entity duly licensed by public health authorities, and the products are duly registered with ANVISA. Nonetheless, distributors and retailers of devices approved for professional use are expected to sell those products accordingly.