Commercialisation of healthcare in Brazil: overview

A Q&A guide to the commercialisation of healthcare in Brazil.

This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in Brazil. It covers the key requirements for manufacturing, advertising and selling drugs, medical devices, biological products and natural health products.

To compare answers across multiple jurisdictions, visit the commercialisation of healthcare Country Q&A tool.

This Q&A is part of the Commercialisation of Healthcare Global Guide. For a full list of jurisdictional Q&As visit www.practicallaw.com/healthcare-guide.

Angela Fan Chi Kung and Julia de Castro Kesselring, Pinheiro Neto Advogados
Contents

Regulatory overview

1. What is the regulatory framework for medical products?

Legislation

Brazil is a civil law country, adopting a codified legal system. Medical devices are regulated by statute and the National Public Health Agency's (Agência Nacional de Vigilância Sanitária) (ANVISA) regulation.

The main legislation is Law No. 6,360 of 23 September 1976, which deals with sanitary surveillance, covering:

  • Medicines.

  • Drugs.

  • Pharmaceuticals.

  • Medical devices.

There are several other laws regulating health matters at the Ministry of Health's (Ministério da Saúde) (MOH) and ANVISA's various department levels. Each state can establish the requirements that it deems necessary for effective sanitary compliance, subject to federal legislation.

Only companies located in Brazil bearing public health licences can perform activities related to medical products and hold product registration.

Regulatory authorities

The Brazilian Federal Constitution has entrusted the provision of public healthcare to the MOH, which is responsible for co-ordinating the Unified System of Health (SUS).

Brazil has also adopted the regulatory agency model for public health surveillance, through ANVISA, an independent agency operating under a special regime and reporting to MOH. ANVISA has the duties of sanitary surveillance, including the powers to regulate and supervise the registration, manufacture, distribution and dispensing of drugs, medical devices and related products and, therefore, to ensure the health and safety of consumers.

The "health authority" encompasses a number of governmental authorities devoted to the protection of health (from ANVISA down to its several departments including state and municipal health departments), supervision of product quality and safety, as well as means of production. This is simultaneously entrusted to the three government levels (federal, state and municipal). Regulations issued by ANVISA apply to the entire country. Although the same authority is granted to other government levels, the scope of these regulations is obviously limited to their respective jurisdictions. The healthcare industry is regulated by MOH and ANVISA at their various department levels.

Each state can establish the requirements that it deems necessary for effective sanitary compliance, subject to federal legislation.

Product registration, clearance of products at ports and airports, certification of good manufacturing practices (GMPs) and compliance with advertising rules are dealt with at the federal level by ANVISA.

Surveillance and inspection of the industries are dealt with at the state or municipal levels.

Private parties

The Brazilian Federal Constitution grants universal access to the healthcare system, which means that the state must provide all citizens with access to healthcare, products and services. However, healthcare activity is open to private initiative, which can complement the public health system, mainly through supplying products and services to the SUS.

Companies, including foreign companies, can now participate in, and control (directly or indirectly), entities that install, operate or exploit general hospitals (including philanthropic and specialised hospitals, polyclinics, general clinics and specialised clinics).

 
2. What types of medical products are regulated?

The following medical products are regulated:

  • Drugs, including new drugs.

  • Generics.

  • Branded generic.

  • Biologics.

  • Herbal.

  • Dynamised (homeopathic or anthroposophic or homotoxicological therapy).

  • Radiopharmaceuticals.

  • Medical devices.

  • Food for special nutrition.

 

Drugs

3. What are the general requirements for a drug to be manufactured, advertised and sold?

A drug can only be manufactured, advertised and sold in Brazil if the National Public Health Agency (ANVISA) has approved its safety and efficacy, that is, after the product registration has been published in the Official Gazette.

Manufacturing

The manufacturer of drugs must have:

  • An actual manufacturing plant.

  • A technician responsible for the activity.

  • Federal health licence to operate (AFE).

  • State licence to operate (LF) per establishment.

  • Special authorisation to operate (AE) for controlled substances, if necessary.

  • Good manufacturing practices (GMP) certificate per production line.

Advertising

Advertising is permitted for products registered in Brazil. Non-prescription (over-the-counter) drugs can be advertised to the public in general. However, drugs sold under prescription can be advertised to physicians or dentists only.

There are several restrictions and warning requirements for the advertising of drugs in Brazil, imposed both by the law and by ANVISA's regulations, including that:

  • Prescription drugs can be advertised to physicians or dentists only through specialised publications.

  • Drugs classified as anodyne that are allowed to be sold over the counter can be advertised in the media (for example, billboards, radio, movies and television) with warnings about their excessive use, as well as the respective contraindications and precautions.

  • The advertising of over-the-counter drugs cannot contain:

    • any statement that cannot be scientifically proven;

    • statements by professionals that are not legally qualified to give them; or

    • texts, pictures, images or projections that lead to misinterpretation, error or confusion on the product's composition, purposes, method of use, origin or properties.

  • Generic products can be advertised in campaigns sponsored by the Ministry of Health (Ministério da Saúde) (MOH) and at the establishments authorised to supply these products, but the reference drug must be expressly mentioned.

  • The advertising of drugs must always contain a warning that a physician must be consulted if symptoms persist.

  • An advertisement cannot contain designations, geographic references, symbols, shapes, drawings or any indications that could lead consumers to misinterpretation, error or confusion related to the product's origins, manufacturing process, nature, composition or quality, or even attribute to the product a purpose or characteristic that differs from those it really has.

  • Drug advertising through the distribution of gifts or giveaways to end consumers and physicians is prohibited. Only institutional gifts are allowed. TV commercials are only allowed for over-the-counter drugs. Full or partial sponsorship by one or more companies for any public or private events, symposia, congresses, meetings, conferences or similar is allowed, provided that the name of the sponsor is disclosed. Such disclosure must be clearly made to the attendee on his enrolment and in the corresponding annals, if applicable. Sponsorship cannot be given to prescription, dispensation or advertisement or publicity of a given drug in any way.

  • Free drug samples can only be distributed to prescribing professionals in outpatient facilities, hospitals, medical and dentistry offices.

ANVISA's resolution on advertising was enacted in December 2008 and came into force in December 2009, leading to several lawsuits challenging ANVISA's regulation. The lawsuits highlighted a discussion on ANVISA's authority to regulate drug advertising, which is exercised through administrative resolutions even though ANVISA has never been granted such powers by law. The Attorney General's Office gave an opinion confirming that ANVISA's powers to regulate drug advertising must be granted by a specific law. However, the legislative branch has not yet enacted a law vesting ANVISA with the authority to regulate the advertising of drugs.

Sale

Sale is permitted once the product is duly registered with ANVISA.

Before launching an innovative drug, new presentation, new pharmaceutical form or new combination of active ingredients or generics, the registration holder must obtain approval of the product maximum selling price from ANVISA's Regulation Chamber of the Drug Market (Câmara de Regulação do Mercado de Medicamentos) (CMED). The maximum selling price is established in accordance with CMED's rules based on international prices or reference prices in Brazil.

Therefore, the manufacturer does not freely define sales prices of these drugs, as ANVISA establishes the maximum selling price to the consumer and to the government.

With the authorisation of the Institutional Review Boards and ANVISA, non-approved drugs can be imported into Brazil for experimental use or compassionate use.

 
4. Are there different requirements for patented and generic drugs?

Although both patented and generic drugs must follow the same laws and regulations, there are different requirements for registration, labelling and pricing of generics.

 
5. What authority is responsible for regulating the manufacture, advertising and sale of drugs?

The National Public Health Agency (ANVISA) is the authority responsible for regulating the manufacture, advertising and sale of drugs, at its various department levels.

Each city or state can establish the requirements that it deems necessary for effective sanitary compliance, subject to federal legislation.

 
6. Are there fewer or different requirements for drugs that have already been licensed/approved in another jurisdiction?

The National Public Health Agency (ANVISA) has its own requirements, which are imposed on all products regardless of their approval status outside Brazil.

However, there are additional requirements for drugs already commercialised in other countries, such as the presentation of an updated pharmacovigilance report.

 
7. Is it possible to sell drugs to or buy drugs from other jurisdictions?

It is possible to sell drugs or to buy drugs from other jurisdictions.

 
8. Is it permitted to advertise drugs to consumers? Are there restrictions on advertising?

It is permitted to advertise non-prescription (over-the-counter) drugs to consumers. However, drugs sold under prescription can be advertised to physicians only.

 

Medical devices

9. What are the general requirements for a medical device to be manufactured, advertised and sold?

A medical device can only be manufactured and sold in Brazil if the product has been registered by or notified to National Public Health Agency (ANVISA). Product approval takes the product risk level into account, that is:

  • A notification process to ANVISA for lower risk products (classes I and II).

  • A registration process to ANVISA for higher risk products (classes III and IV).

The approval of medical devices classified as lower risk products is valid for an undetermined period of time, while the approval of medical devices classified as higher risk products is valid for five years.

Certain categories of medical devices also require certification from the Brazilian standardisation authority (INMETRO) or the national nuclear energy committee (CNEM).

Manufacturing

The manufacturer of medical devices in Brazil must have:

  • An actual manufacturing plant.

  • A technician responsible for the activity.

  • Federal health licence to operate (AFE) per establishment.

  • State or municipal licence to operate (LF) per establishment.

  • Good manufacturing practices (GMPs) certificate per production line for products under the risk classes III and IV.

Advertising

Brazil has not yet regulated the advertising of medical devices. However, as a rule, advertisements of medical devices must comply with the registration of the products before ANVISA. General advertising rules from the Consumer Protection Code also apply to medical devices.

Sale

Sale is permitted once the product is duly registered with ANVISA. The prices of medical devices are not controlled by ANVISA. However, the product registration holder must provide an economic report about the price of the product during the registration process.

Unregistered medical devices can be imported for experimental use, for individual use under a physician responsibility or on a temporary basis for exhibition purposes.

 
10. What authority is responsible for regulating the manufacture, advertising and sale of medical devices?

The National Public Health Agency (ANVISA) is the authority responsible for regulating the manufacture, advertising and sale of medical devices, at its various level departments.

Each city or state can also establish the requirements that it deems necessary for effective sanitary compliance, subject to federal legislation.

In addition, the Brazilian Standardisation Authority (INMETRO) and/or the National Nuclear Energy Committee (CNEM) are responsible for regulating the manufacture, advertising and sale of certain products, subject to federal legislation.

 
11. Are there fewer or different requirements for medical devices that have already been licensed/approved in another jurisdiction?

The National Public Health Agency (ANVISA) has its own specific requirements that are imposed on all products regardless of their approval status outside Brazil.

 
12. Is it possible to sell devices to or buy devices from other jurisdictions?

It is possible to sell devices to or buy devices from other jurisdictions.

 
13. Is it permitted to advertise medical devices to consumers? Are there restrictions on advertising?

It is permitted to advertise medical devices to consumers. Brazil has not yet regulated the advertising of medical devices but there are general advertisement restrictions established by the Consumer Protection Code that apply to medical devices, such as the prohibition on advertising products through phone calls, when the call at the consumer's cost.

 

Biological products

14. What are the general requirements for a biological product to be manufactured, advertised and sold?

Biological products can only be manufactured, advertised and sold in Brazil after product registration at the National Public Health Agency (ANVISA).

A new biological product (never registered before in Brazil) must be submitted to a new and complete development process (individual development path), in which the presentation of all data on the development, production, quality control and non-clinical and clinical data of the product must demonstrate the quality, efficacy and safety of the product. Biological products that are not new (that is they are already registered in Brazil) can be registered in two different ways:

  • Individual development.

  • Comparability, in which the product subject to comparison was compared to the comparator product in terms of quality, efficacy and safety.

Manufacturing

The manufacturer of biological products in Brazil must have:

  • An actual manufacturing plant.

  • A technician responsible for the activity.

  • Federal health licence to operate (AFE).

  • State licence to operate (LF) per establishment.

  • Special authorisation to operate (AE) for controlled substances, if necessary.

  • Good manufacturing practices (GMP) certificate per production line.

Advertising

The advertising rules that are applicable to drugs are also applicable to biological products. Biological products can be advertised after product registration at ANVISA (see Question 3). However, the distribution of free sample of biological products is prohibited.

Sale

Sale is permitted once the product is duly registered with ANVISA.

Before launching an innovative biological drug, a new presentation, new pharmaceutical form or new combination of active ingredients, the registration holder must obtain approval of the maximum selling price from CMED. The maximum selling price is established in accordance with CMED's rules based on international prices or reference prices in Brazil.

Therefore, the manufacturer does not freely define sales prices of these drugs, as ANVISA establishes the maximum selling price to the consumer and to the government.

With the authorisation of the Institutional Review Boards and ANVISA, non-approved drugs can be imported into Brazil for experimental use or compassionate use.

 
15. What authority is responsible for regulating the manufacture, advertising and sale of biological products?

The National Public Health Agency (ANVISA) is the authority responsible for regulating the manufacture, advertising and sale of biological products, at its various department levels.

Each city state can also establish the requirements that it deems necessary for effective sanitary compliance, subject to federal legislation.

 
16. Are there fewer or different requirements for biological products that have already been licensed/approved in another jurisdiction?

The registration of biological products manufactured outside Brazil depends on the approval and release of the product for use in the country where it is manufactured. If the product is not registered in the manufacturing country, but in a country with epidemiological demand, the National Public Health Agency (ANVISA) can, exceptionally, approve the drug in Brazil.

 
17. Is it possible to sell biological products to or buy biological devices from other jurisdictions?

It is possible to sell biological products to or buy biological devices from other jurisdictions.

 
18. Is it permitted to advertise biological products to consumers? Are there restrictions on advertising?

The advertising rules for drugs apply to biological products. It is therefore permitted to advertise non-prescription (over-the-counter) biological products to consumers. Biological products sold under prescription can be advertised to physicians only. In addition, free samples of biological products cannot be distributed.

 

Natural health products

19. Is there a category for natural health products (including, for example, traditional medicines, homeopathic medicines, supplements, vitamins and minerals)?

Natural health products can fall into four categories:

  • Special drugs. This covers drugs such as polyminerals.

  • Herbal drugs. This covers drugs obtained from the exclusive use of active vegetable raw materials, the efficacy and safety of which are validated through ethno-pharmacological and utilisation surveys, techno-scientific documentation or clinical evidence.

  • Dynamised drugs. This covers drugs prepared from substances that undergo crushing or successive dilutions followed by succussion or other forms of rhythmic agitation that is used for preventive or curative purposes and is administered as homeopathic, anthroposophic or homotoxicological therapy.

  • Food for dietary supplement. This covers a vitamin supplement or enteral nutrition products.

 
20. What are the general requirements for natural health products to be manufactured, advertised and sold?

Except for vitamin supplements, natural health products can only be manufactured, advertised and sold in Brazil after product registration at the National Public Health Agency (ANVISA).

Manufacturing

The manufacturer of natural health products in Brazil must have:

  • An actual manufacturing plant.

  • A technician responsible for the activity.

  • Federal health licence to operate (AFE).

  • State licence to operate (LF) per establishment.

  • Special authorisation to operate (AE) for controlled substances, if necessary.

  • Good manufacturing practices (GMP) certificate per production line.

Advertising

The advertising rules applicable to drugs are also applicable to natural health products that falls into the drug category (J). ANVISA has not regulated the advertising of natural products that fall into the food category, but general consumer protection rules apply to the natural health products.

Sale

Sale is permitted once the product is duly registered with ANVISA.

 
21. What authority is responsible for regulating the manufacture, advertising and sale of natural health products?

The National Public Health Agency (ANVISA) is the authority responsible for regulating the manufacture, advertising and sale of natural health products, at its various level departments.

Each city or state can also establish the requirements that it deems necessary for effective sanitary compliance, subject to federal legislation.

 
22. Are there fewer or different requirements for natural health products that have already been licensed/approved in another jurisdiction?

The National Public Health (ANVISA) has its own requirements that are imposed on all products regardless of their approval status outside Brazil.

 
23. Is it possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically?

It is possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically.

 
24. Is it permitted to advertise natural health products to consumers? Are there restrictions on advertising?

It is permitted to advertise natural health products to consumers. Natural health products that fall into the drug category are subject to the advertising rules for drugs (see Question 3).

 

Reform

25. Are there any plans to reform the rules on the development, manufacture, advertising and sale of medical products?

A bill concerning clinical trials is under discussion before the Brazilian Congress, and will be the first law regulating clinical trials. A recently published provisional measure grants powers to the Regulation Chamber of the Drug Market to increase or reduce the prices of pharmaceuticals. This provisional measure is currently being discussed and may either be converted into law or abolished within a timeline set by the law.

 

The regulatory authorities

Ministry of Health (Ministério da Saúde) (MOH)

W http://portalsaude.saude.gov.br

Principal responsibilities. The MOH is responsible for the public healthcare policies and clinical protocols, as well as for regulation of non-traditional medical treatments.

National Public Health Agency (Agência Nacional de Vigilância Sanitária) (ANVISA)

W http://portal.anvisa.gov.br/wps/portal/anvisa/home ( www.practicallaw.com/2-378-8731)

Principal responsibilities. ANVISA is the public health watchdog, with powers to regulate the registration, manufacturing and distribution of pharmaceutical products, medical devices, food, cosmetics and cleaning products, therefore ensuring the health and safety of consumers. Product registration, clearance of drugs at ports and airports, certification of good manufacturing practices and compliance with advertising rules on drugs are handled at the federal level by ANVISA. The control of import, production and sales activities is simultaneously entrusted with the state and municipal health offices.



Online resources

Brazilian Presidency website

W www.planalto.gov.br

Description. The Brazilian Presidency website contains updated versions of the Constitution and its amendments, supplementary, ordinary and delegated laws, provisional measures and decrees.

Senate website

W www.senado.gov.br

Description. The Senate website contains updated versions of the Constitution and its amendments, supplementary, ordinary and delegated laws, provisional measures and decrees (in Portuguese).

National Public Health Agency (Agência Nacional de Vigilância Sanitária) (ANVISA)

W www.anvisa.com.br

Description. Sanitary ordinances and regulations can be found on ANVISA's website. However, this does not always provide current versions of these legal documents. The most reliable sources for updated sanitary regulations are law firms or other paid sources of information and their databases are all in Portuguese.

Ministry of Health (Ministério da Saúde) (MOH)

W www.saude.gov.br

Description. Sanitary ordinances and regulations can be found on the MOH website. However, this does not always provide current versions of these legal documents. The most reliable sources for updated sanitary regulations are law firms or other paid sources of information and their databases are all in Portuguese.



Contributor profiles

Angela Fan Chi Kung, Partner

Pinheiro Neto Advogados

T +55 1132478685
F +55 1132478600
E akung@pn.com.br
W www.pinheironeto.com.br

Professional qualifications. Lawyer, Brazil, 1992

Areas of practice. Life sciences; intellectual property.

Recent transactions

  • Advising Pfizer in several corporate transactions and regulatory matters.

  • Advising Merck Sharp & Dohme in the PDP with Instituto Butantan for the production of the HPV vaccine.

Languages. Portuguese, English

Professional associations/memberships

  • Brazilian Bar Association.

  • São Paulo Bar Association.

  • Sanitary Law Committee.

  • Volunteer member of the IRB of Universidade Federal do Estado de São Paulo (UNIFESP).

Julia de Castro Kesselring, Associate

Pinheiro Neto Advogados

T +55 1132476195
F +55 1132478400
E jkesselring@pn.com.bt
W www.pinheironeto.com.br

Professional qualifications. Lawyer, Brazil, 2015

Areas of practice. Life sciences.

Recent transactions

  • Advising Pfizer in several corporate transactions and regulatory matters.

  • Advising several companies in the medical devices industry on interactions with healthcare professionals and compliance matters.

  • Advising pharmaceutical companies in partnerships for technology transfer to public pharmaceutical companies (PDPs).

Languages. Portuguese, English

Professional associations/memberships

  • Brazilian Bar Association.

  • São Paulo Bar Association.


{ "siteName" : "PLC", "objType" : "PLC_Doc_C", "objID" : "1248207136745", "objName" : "ACT_OWNED - READ_ONLY - 5-617-6463", "userID" : "2", "objUrl" : "http://us.practicallaw.com/cs/Satellite/us/resource/5-617-6463?null", "pageType" : "Resource", "academicUserID" : "", "contentAccessed" : "true", "analyticsPermCookie" : "2-3b01f5d1:15afbae4ce5:6867", "analyticsSessionCookie" : "2-3b01f5d1:15afbae4ce5:6868", "statisticSensorPath" : "http://analytics.practicallaw.com/sensor/statistic" }