State intervention in the economy
Brazilian regulatory legislation has been updated in line with the trends directed by the country’s economic and social development and the world. Currently, there is no doubt that the economic scenario is globalized. Therefore, the regulatory alignment of developed and developing nations is increasingly crucial for promoting commercial, financial and economic practices. A latent sign of the scenario presented is the ongoing efforts employed by Brazil to integrate the select group of countries members of the OECD (Organization for Economic Cooperation and Development).
Regulatory Law in Brazil has ceased to be an obstacle to economic development, and it has increasingly been deemed as a means of communication and adjustment to the market’s needs. The result has promoted the duties of the public sector of police, management and surveillance of activities in the society.
17.2 Brazilian regulatory law in the areas of Health (Life Sciences), Food and Technology
17.2.1 Regulatory Law in health – Life Sciences
Regulatory Law applicable to life sciences and health must be assessed from the perspective of a federative country. This includes the coordinated action of federal, state and municipal health authorities. At the federal level, the National Health Surveillance Agency (“ANVISA”) has jurisdiction, among others, to coordinate the National Health Surveillance System and promote the protection of the population’s health by controlling the production and commercialization of some products and services subject to health surveillance. At the state and municipal levels, we have Local Health Surveillance Authorities with additional jurisdiction over the Union for specific issues related to health protection, including inspection and licensing of activities within their jurisdictions. For more information, please see item 19.
The Life Sciences industry address and deals with sciences that, in any way, relate to living organisms such as plants, animals, and human beings, including the development of pharmaceuticals, health products, cosmetics, personal care products, sanitizing products, cannabis-based products, food, among others. It is a highly regulated and complex segment wherein each product category has its regulation under the terms of the applicable health legislation. Below we will present brief notes on the regulations applicable to such products, except for medicines, which is dealt with in item 19 of this Guide.
In general, a company in the industry that intends to carry out its activities in Brazil must obtain specific licenses and authorizations for the company itself and for products from ANVISA and other decentralized bodies that are part of the National Health Surveillance System, such as Local Health Surveillance Authorities, including state and municipal. Among the main applicable licenses and authorizations are: (i) federal operation authorization (AFE) issued by ANVISA; (ii) local license to operate the establishment (LF) issued by the state or municipal Health Surveillance Authority, depending on the location and type of activity to be conducted; (iii) product registration, registry or notice with ANVISA; and (iv) certification of good practices.
Health products are defined as equipment, apparel, implant, software, materials, and devices intended for prevention, diagnosis, treatment, monitoring, rehabilitation or contraception, support or maintenance of life, and which do not use pharmacological, immunological or metabolic means to perform their primary function in human beings, being able however to be aided in its functions by such means. It is a vast list of products in several categories, such as in vitro diagnostics, medical equipment, orthopedic implants and materials for use in health.
Health products are divided into 4 risk classes, according to the rules of ANVISA applicable regulation, currently Resolution RDC 751/22.
The products classified in Classes III and IV, as they are of high and maximum risk, are subject to registration with the Agency. These products include infusion pumps, anesthesia kits, catheters, orthopedic fixation systems and associated devices, the system for injecting radiological contrast, surgical wires and tapes, hearing implants and stents. Registration with ANVISA is valid for 10 years.
The products classified in Class I and II, as they are of low and medium risk, respectively, are subject to notice. For example, class I and II products are products for orthodontics (bracket, wire, cement and components), bandages, adhesive tapes, bandages, wheelchairs, collection bags, probes, contact lenses and disposable needles and syringes. The notice is valid for an undefined time.
By applying the rules provided for in Resolution RDC 751/22, the company is responsible for defining and classifying its product in the applicable class. The application of the regulations is governed by the product’s intended purpose (the use for which the product is designed, according to the manufacturer’s information). If the product falls into multiple risk classes, the strictest rule and sub-rule that lead to the higher classification apply.
Health products can also be classified as Software as a Medical Device (SaMD), which is a product or application intended for one or more purposes of health products and performs functions without being part of the hardware of a medical device. The following software are not SaMD: wellness, used exclusively for administrative and financial management in health services; which processes demographic and epidemiological medical data without any clinical diagnostic or therapeutic purpose; shipped in a medical device under health surveillance, among other hypotheses. SaMD is regulated by Resolution RDC 657/22. SaMD may be subject to registration or notice, considering the classification rules provided in Resolution RDC 751/22.
In turn, products for in vitro diagnosis are also divided into 4 classes of risk, considering the risk to the individual and the threat to public health, according to Resolution RDC 36/15. The criteria used to classify products for in vitro diagnosis are, among others, the indication of use, the importance of the information provided to the diagnosis, and the relevance and effect of the result for the individual and public health.
After being introduced to the market, the health product must be monitored by the responsible company (manufacturer or importer) to monitor any possible deviation from safety and effectiveness. Variation can be understood as the departure from product quality parameters with a risk to patient safety and health. In case of variation, the company should generally initiate a field action procedure to reduce the risk of collateral effects related to the use of a medical product already sold under the terms of Resolution RDC 551/21.
Personal hygiene products, cosmetics and perfumes are defined as preparations consisting of natural or synthetic substances, for external use in the various parts of the body, with the sole or primary purpose of cleaning, perfuming, altering their appearance and/or correcting body odors, and either protecting them or keeping them in good condition, are also divided into categories, currently established by Resolution RDC 752/22. They are:
- Grade 1: they have primary or elementary properties, the proof of which is not initially necessary and does not require detailed information on how to use and restrictions. Examples of Grade 1 products are perfumes, lipstick and lip gloss, some makeup (without photo-protection purpose), makeup remover, deodorant (except those with antiperspirant action) and nail polish.
- Grade 2: have specific indications that require proof of safety and/or efficacy, in addition to information and care, mode and use restrictions. Examples of Grade 2 products are suntan lotion, sunscreen (including for use by children), hair straightening and dyeing products, and insect repellent (including for use by children).
Only some products are subject to registration proceeding with ANVISA: suntan lotion, antiseptic hand gel, hair straightening and dyeing products, hair curling products, sunscreen and insect repellent. Registration is also valid for 10 years. The other products are subject to prior communication with ANVISA.
Such ANVISA Resolution also determines mandatory labeling criteria for personal hygiene products, cosmetics and perfumes. Objectively speaking, the following information, among others, has to be provided: product name and category to which it belongs, brand, product registration number, batch, expiration date, country of origin, holder, method of use, warnings and restrictions of service (if applicable), ingredients/composition and specific labeling, if necessary.
With the appearance of organic products for personal hygiene, cosmetics and perfumes, ANVISA has included the issue of regularization of organic products in its regulatory agenda, alleging the existence of a Law and Decree (that is, Law 10.831/03 and Decree 6.323/07) that define the requirements for organic products. Still, the absence of specific requirements for organic cosmetic products has made it difficult to certify this product category. Any news on the subject will only appear in 2024.
Sanitizers are products defined as a substance or preparation for application on objects, fabrics, inanimate surfaces and environments intended for cleaning, hygiene, sanitation and disinfection. Examples of sanitizers are insecticides, rodenticides, disinfectants and detergents. Among other categories, sanitizers are classified according to their risk, sale and use.
As for risk, sanitizers are divided into (i) products of risk I, which are subject to notice; and (ii) products of risk II, which are subject to registration. The requirements that must be met for each product category and type are provided in Resolutions RDC 692/22, RDC 59/10 and RDC 697/22. The sanitizing registration is valid for 10 years.
As for sale and use, sanitizers are divided into two categories: (i) for professional use, which may not be sold directly to the public, and have to be applied or handled exclusively by a professional or specialized company; and (ii) over-the-counter sanitizing product, which is the product that can be sold to the public. ANVISA has specific rules for each type of sanitizing product about its labeling.
Still, cannabis-based products are regulated exclusively for human medicinal use in Brazil and with a predominant composition of cannabidiol, which may have a low presence of tetrahydrocannabinol. There are three ways to access a cannabis-derived product whose situations and regulatory classifications are different:
- Via exceptional importation of a product for treating one’s health, regulated by Resolution RDC 660/22. In this case, the patient imports a product regularized in the country of origin for his treatment upon medical prescription and prior registration with ANVISA. The patient is prohibited from selling the imported product to a third party; the product aims exclusively at your treatment.
- Via the acquisition of a cannabis product regulated by Resolution RDC 327/19. In this situation, the company and the product must be regularized at ANVISA, obtaining authorizations and licenses in the cannabis product modality. The validity of the Sanitary Authorization for cannabis products is 5 years, which cannot be extended. After this period, the product must be regularized as a medicine. Resolution RDC 327/19 is being revised by ANVISA, with the publication of a rule expected for 2023/2024.
- Via acquisition of medicines composed of cannabidiol. In this case, the product is regularized via the pharmaceutical rite, with the need to obtain licenses and authorizations from the company and register the product (valid for 10 years, extendable).
17.2.1 Regulatory Law in the Food Industry
In Brazil, food is regulated mainly by two bodies: (i) the Ministry of Agriculture and Livestock (“MAPA”); and (ii) the National Health Regulatory Agency (“ANVISA”). MAPA regulates animal products, beverages (alcoholic and non-alcoholic), and fresh vegetable products. ANVISA is responsible for regulating and controlling processed foods in general, food additives and technology aids, packaging, equipment and devices in contact with food, and inspecting food in commerce.
Depending on the food, the establishment and the food must be registered with MAPA. For example, vegetable products that must be registered with MAPA are those standardized by the Ministry under the terms of Law 9.972/00 and its regulations. The products can be verified in a list available on the MAPA website1. In turn, establishments that carry out interstate or international sales of animal products have to be registered with the Department of Inspection of Animal Products, as determined by Decree 9.013/17.
Within the scope of ANVISA, the foods that must be registered are established by Exhibit II of Resolution RDC 27/10, such as foods with functional or health claims, children’s foods, enteral nutrition formulas, and new foods and new ingredients. Registration is valid for 5 years. There are also foods exempt from registration, but the company must inform the Local Health Surveillance Authority of the beginning of their manufacture (Exhibit I of Resolution RDC 27/10). This is the case with foods for weight control, chocolate and cocoa products, vegetable oils, vegetable fats and vegetable cream, cereal products, starches, flours and bran. The procedures are detailed in Resolutions RDC 22/00 and RDC 23/00.
ANVISA also determines the technical regulation of food. That is, it establishes some food’s identity and minimum quality characteristics. For example, starches, biscuits, whole grains, processed cereals, bran, flour, whole meal flour, pasta and bread are regulated by Resolution RDC 711/22.
Food labeling is also the responsibility of ANVISA. The mandatory elements are, for example, the sale name of the food, list of ingredients, net content, origin, batch, expiration date and nutritional information (nutritional table) (Resolution RDC 727/22). Some rules require the inclusion of additional information in the labeling: warning on the presence of Genetically Modified Organisms (Decree 4.680/03); warning on the presence of gluten (Law 10.674/03); declaration on the presence of lactose (Resolution RDC 727/22), and warning on the presence of some food that causes food allergies (Resolution RDC 727/22).
17.2.1 Regulatory Law in the Technology Industry
The UN Convention on Biological Diversity defines biotechnology as using knowledge about biological processes and the properties of living beings to solve problems and create valuable products.
In a broader sense, it comprises handling microorganisms, plants and animals to obtain processes and products of interest to society. Strictly speaking, it refers to state-of-art molecular and cellular biology techniques, including genetic engineering.
The regulatory framework for biotechnology in Brazil aims to reconcile essential issues related to national sovereignty over genetic resources, the strengthening and competitiveness of the national bio-industry, the biosafety of living beings and the environment, and the right to information and free choice of consumers.
In this scenario, it is worth highlighting the main regulatory aspects of Brazil’s increasingly essential biotechnology issues: The regulation of GMOs and the regulation of activities with genetic heritage and traditional knowledge associated with the Brazilian biodiversity.
Genetically Modified Organisms (GMOs) and their by-products (products obtained from GMOs with no autonomous capacity to replicate or with no viable form of GMOs) are all changed by receiving one or more genes via genetic technology. Given the risks that such changes may pose to the ecosystems, agriculture and human health, they are subject to national and international biosafety standards.
Among GMOs, the transgenic that has been applied in several industries stands out, among which:
- agriculture, with versions of soy, corn, cotton, pumpkin, sugar beet, sugar cane, beans, and transgenic papaya;
- health, in the development of insulin for the treatment of diabetes, as well as for immunizations and other medicines; food, with fungi, yeast and transgenic bacteria applied in cheese, wine, beer, and bread manufacturing processes, among others;
- chemicals in creating transgenic enzymes for degreasing cleaning products, such as soap and detergents.
The primary standards related to GMOs, their by-products and biosafety in Brazil are Law 11.105/05 (“National Biosafety Policy”) and its Decree 5.591/05, which establish safety standards and inspection mechanisms on construction, cultivation, production, handling, transport, transfer, import, export, storage, research, sale, consumption, release into the environment and disposal of GMOs and their by-products in the country. Other rules related to the issue may be found at http://ctnbio.mctic.gov.br/normas-e-leis. To conduct any activities with GMOs and their products in the Country, it is necessary the issue the Biosafety Quality Certificate (“CQB”) by Comissão Técnica Nacional de Biossegurança (the National Technical Biosafety Commission) (“CTNBio), an advisory deliberative multidisciplinary collegiate body, linked to the Ministry of Health, Science, Technology, Innovations and Communications. CTNBio is also responsible for monitoring the technical and scientific development and progress in biosafety, biotechnology and bioethics.
In addition, they are bodies for registration and inspection of GMO-containing products and their by-products: Ministry of Agriculture and Livestock (“MAPA”), Instituto Brasileiro do Meio Ambiente e dos Recursos Naturais Renováveis (the Brazilian Institute of the Environment and Natural Renewables Resources (“IBAMA”) and the National Health Surveillance Agency (“ANVISA”).
By Law 11.105/05, food and ingredients intended for human or animal consumption, which contains or are produced from GMOs or by-products in any percentage, must include information on their labels. Labeling is regulated by Decree No. 4.680/2003.
Previously, only products with GMOs over 1% should have the information on the label. However, due to recent decisions rendered in two public civil actions, which dealt primarily with consumers’ right to information, the determination of labeling in any percentage has become mandatory for all products with GMOs.
As Brazil is a signatory member of the Convention on Biological Diversity – (“CDB”), it is required to observe the guidelines on biodiversity, which in summary, have three primary objectives: (i) conservation of biological diversity, (ii) sustainable use of natural resources, and (iii) fair and equitable sharing of their benefits. To this end, Brazilian legislation has been evolving regarding the rules and procedures for regulating activities with its biodiversity components to ensure compatibility with the CDB objectives and the protection of its biodiversity resources.
The legal framework for Brazilian biodiversity is composed of Federal Law 13.123/15 (“Biodiversity Law”) and its Decree 8.772/16, in addition to other rules and guidelines issued by Conselho de Gestão do Patrimônio Genético (the Management Board of the Genetic Heritage (“CGEN”), linked to the Ministry of the Environment and Climate Change (“MMA”), responsible for the coordination, development and implementation of policies for management of genetic heritage (“PG”) and related traditional knowledge (“CTA”) to Brazilian biodiversity.
The activities associated with PG consist of actions that use generic information on plant, animal, microbial species (bacteria, microalgae, etc.), fungi of Brazilian biodiversity, as well as microorganisms that have been isolated from substrate existing in the national territory, the territorial sea, the exclusive economic zone or the continental shelf.
In turn, activities with CTA use information or practices from indigenous populations, communities or traditional farmers about the properties or direct/indirect uses associated with PG.
By the rules in force on the matter, activities involving PG and CTA, inclusive, without limitation, access for technological research or development, forwarding of samples abroad, and notice of exploration of finished product or reproductive material, among others indicated in the Biodiversity Law, must have a registry with SISGEN (Sistema Nacional de Gestão do Patrimônio Genético (the National Genetic Heritage Management System), an online platform operated by CGEN.
It is worth mentioning that the Brazilian Biodiversity Law does not apply to human genetic heritage, nor does it allow access to the PG or CTA to be made by foreign individuals or access to practices harmful to the environment, cultural reproduction and the health of humans.
Authors: Benny Spiewak and Daniela Guarita Jambor
SPLAW – Spiewak e Carneiro Advogados
Al. Campinas, 1.077 – 12º andar
BR-01404-001 São Paulo – SP
Phone (11) 2039 0130