The Life Sciences and Healthcare sector in Brazil is highly regulated, encompassing all sorts of products that represent risks to health, hospital, clinical, commercial activities in connection to healthcare, including the newest trends such as cannabis-based products, software as a medical device and products for the diagnosis and treatment of COVID-19.
- LIFE SCIENCES
2.1 OVERVIEW OF THE BRAZILIAN life sciences regulation
According to the International Bar Association (IBA), the life sciences and healthcare sector “is concerned with those fields of science that involve the scientific study of living organisms, with a special focus on all aspects of healthcare law, including such areas as medicine law, intellectual property, biotech, bioethics, regulatory issues and scientific developments (…)”.
This means that, in Brazil, the life sciences field is directly subject to the sanitary surveillance regulation. Pursuant to Federal Law No. 8,080/1990, “the sanitary surveillance is understood as the range of actions capable of eliminating, reducing or preventing risks to health and intervening on sanitary issued caused by the environment, the manufacture and circulation of goods and service rendering ‘of health interest”.
In this sense, the public authorities are competent to intervene in the private sector, in relation to those who manufacture and circulate goods and render services of health interest, to prevent risks and, thus, damages to human health.
One of the entities to which this duty/power has been assigned to is the National Sanitary Surveillance Agency (“ANVISA”), an entity part of the Ministry of Health (“MoH”) that has as its institutional purpose to “ensure the population’s health protection, by means of the sanitary control of the production and trade of products and services subject to sanitary surveillance, including associated establishments, processes, inputs and technologies (…)”.
Such control can be expressed, mainly, as the need for the company that performs activities of health interest (that is, that can cause damage to health) to be granted several permissions by the State to operate.
This applies regarding the company’s operation itself as well as e.g. the trade of every product it manufactures, imports or in any form processes, among other requirements.
The main requirements so that companies subject to sanitary surveillance may perform their activities are generally listed below. We stress that such requirements may vary depending on the company’s specific activities and/or products manufactured. Thus, references below should be adapted to each and every specific situation.
2.2 MAIN SANITARY REQUIREMENTS
2.2.1 COMPANY’S OPERATION PERMIT
The permission for private entities to operate, on a federal level, with products subject to sanitary surveillance corresponds to the Operation Permit (“AFE”), necessary to establishments that perform storage, distribution, packaging, expeditions, exportation, extraction, manufacturing, fractioning, importation, production, purification, repackaging, synthesis, transformation and transport activities of drugs and pharmaceutical inputs intended for human use, cosmetics, products for personal hygiene, perfumes, household sanitizers and packaging of medical gases. Even though food is subject to sanitary surveillance, food industries and service renderers are exempt from obtaining an AFE.
On a local level, i.e. state and or municipal level, the licensing of the establishment that performs activities of health interest, as established by each local regulation, is required, food industries and service renderers included in this case.
The reason of the need for previous approval of the establishment by the authorities is, exactly, preservation of health, as a prevention to the risk the activities mentioned above represent.
That is what can be interpreted from the requirements to obtain an AFE: assuring the establishment has set a quality system, hygiene conditions, storage and operation suit to the product’s needs, so as to reduce the contamination risk, risk of altering its characteristics, etc.
2.2.2 MARKETING AUTHORIZATIONS: REGISTER AND NOTIFICATION
As to products of health interest, therefore, subject to health surveillance: drugs, pharmaceutical inputs, health products, products for personal hygiene, perfumes, cosmetics, household sanitizers, products for esthetic purposes, depending on the risk they represent as set by the law, are subject to register or notification before ANVISA.
They are kinds of authorizations so that the products may be put in the market after their quality, efficiency and safety has been attested: register applies for products that represent a greater risk to health, whereas notification applies for smaller risks, as established by each specific regulation (e.g. drugs, health products, cosmetics).
Some food products may also be subject to registration with ANVISA, pursuant to Decree-Law No. 986/1969. However, food products are normally exempt from registration and are subject to a prior manufacturing communication to ANVISA before they are marketed.
2.2.3 Certification of Good Manufacturing Practices (GMP CERTIFICATE)
Depending on the potential of risk to health, a specific certification is necessary for the manufacturing of certain products (such as drugs, active pharmaceutical inputs and high-risk health products), as granted by ANVISA, attesting that the manufacturing facility complies with Good Manufacturing Practices (“GMP”).
In order to grant this Certification of Good Manufacturing Practices, normally an ANVISA’s server inspects the company’s manufacturing facility to check if the technical regulation with regard to the manufacturing of such product is being totally complied with. Inspection to certify Good Manufacturing Practices in establishments located in Brazil can also be carried out by the local health surveillance (of the corresponding State or municipality).
In case of imported products, ANVISA’s server usually travels to manufacturing site abroad. Even though several countries demand a GMP Certificate, the requirements established by each country are different, in spite of the fact that, in the last years, ANVISA has been adopting actions to standardize criteria.
The GMP Certificate is applicable to most industries of products of health interest but is not a mandatory license, even though it is required for importation procedures. However, several rules establishing Good Manufacturing Practices exist in connection to different products with which industries and service providers need to comply with.
ANVISA has been admitting pieces of reports and opinions issued by other international entities for certain situations, however, it remains as the competent authority to grant the GMP Certificate to manufacturers of products put in the Brazilian market.
In this sense, ANVISA is a certified agency by the Medical Device Single Audit Program (MDSAP) “a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions”: Australia, Brazil, Canada, Japan and the United States.
Thus, if a company located at any of the countries above wishes to export their medical devices to Brazil, they may be subject to a single local audit, which shall be valid in Brazil, that is, ANVISA’s sever would not need to inspect the manufacturing facility.
Since January 2021, ANVISA is a member of the Pharmaceutical Inspection Co-operation Scheme – PIC/s, whose institutional purpose is the cooperation between regulatory authorities in the field of Good Manufacturing Practices (GMP) of medicinal products for human or veterinary use.
2.3 NEW PRODUCTS AND SCENARIOS
Brazilian regulation on sanitary surveillance is very broad and, as products and technology evolve, ANVISA has been regulating new matters. We have listed below some of the trends and latest matters in connection with sanitary surveillance in Brazil.
2.3.1 CANNABIS PRODUCTS
The Drugs’ Law (Law No. 11.343/2006) laid the foundation for cannabis-based products to be used for medical purposes in Brazil.
In 2014 , the Federal Medical Council (“CFM”) regulated the prescription (CFM Resolution No. 2,113/2014) of cannabidiol-based products, further developing the matter in Brazil and making way to more advances.
In 2015, ANVISA regulated, for the first time, the direct importation of cannabis-based products, by an individual person, for personal use, through a prescription issued by a legally qualified professional, for health treatment (ANVISA Resolution No. 17/2015, revoked by ANVISA Resolution No. 335/2020).
The main measure was the publication of ANVISA Resolution No. 327/2019 in December 2019, which regulates the procedure of authorization for national manufacturing and importation of cannabis products for medical purposes. ANVISA Resolution No. 327/2019 entered into force in March 10, 2020 and will be reviewed after 3 years.
This new regulation has created a new regulatory category, that of “cannabis-based products”. This category is subject to fewer sanitary requirements compared to drugs, for instance – without prejudice to cannabis-based products having their MA filed for fitting in the “drug” category – and has been allowing patients and market agents to handle cannabis products for medical purposes more safely.
Further regulation is expected, including by the Ministry of Agriculture, Livestock and Supply (“MAPA”), especially concerning cannabis cultivation for medical purposes, which is prohibited in Brazil at this point.
Cosmetics and cannabis-based foods are currently not allowed in Brazil.
Software for healthcare purposes are more and more present in our lives, by means of programmes that process our routine medical exams to applications in our smartphones.
Considering the current Brazilian regulation, health software is encompassed in the “health product” category and, thus, could be subject to register or notification before ANVISA.
The regulation regarding the registration of health products was edited in 2001 (ANVISA Resolution No. 185/2001). Thus, the rule is prior to the diffusion of software as a technology applied to health.
So far, ANVISA has not issued a specific regulation regarding software for healthcare. ANVISA provided some guidelines through Technical Note No. 4/2012, which classified health software in three categories: (a) software as a health product (medical device), by itself, (b) software as part (or accessory) of a health product (medical device), (c) software that is not a health product (not classified in the previous categories).
However, given the specificity of such products, ANVISA intends to draft a special regulation for software, but it is still under discussion.
2.3.3 PRODUCTS IN THE CONTEXT OF COVID-19
In spite of the fact that products intended for the prevention, diagnosis or treatment of the new coronavirus (Sars-CoV-2/Covid-19) do not form a new regulatory category of their own, fitting into the drug, health product, household sanitizers or cosmetics categories, ANVISA has been very active in issuing acts in order to make it easier for such products to be regularized and, thus, used in Brazil to fight the disease.
For example, we highlight the following regulatory modifications:
- By means of ANVISA Resolution No. 357/2020 the remote delivery of controlled drugs, has been allowed, provided that certain requirements are met.
- ANVISA Resolution No. 350/2020 allowed duly licensed drug, sanitizing product and cosmetics manufacturers to produce and trade antiseptic substances or disinfectant products, temporarily and extraordinarily, without previous authorization.
- ANVISA Resolution No. 349/2020 regulated extraordinary and temporary procedures for applications concerning the regularization of individual protection equipment, medical devices related to lung ventilation, and other medical devices recommended for Covid-19 diagnosis or treatment, among other acts.
- ANVISA Resolution No. 378/2020 allowed, exceptionally and temporarily, the importation, commercialization, and donation of used pulmonary ventilators, vital signs monitors, infusion pumps, oximetry equipment and capnographs, indispensable in intensive care units and essential to combat Covid-19, provided that the products have or have already had a marketing authorization issued by ANVISA.
- ANVISA Resolution No. 448/2020 regulated the manufacturing, importation and commercialization of personal protective equipment (such as surgical masks, particulate respirators N95, PFF2 or equivalent, goggles, face shields, disposable hospital gowns, caps and vests) identified as a priority for use in health services due to the pandemic.
- ANVISA Resolution No. 483/2021 facilitated the importation of new medical devices and drugs identified as priorities for use in health services due to the international public health emergency related to Sars-Cov-2.
- ANVISA Resolution No. 475/2021 established procedures and requirements for the submission of request for temporary emergency use authorization (local acronym “AUE”) of drugs and vaccines for Covid-19, in experimental character, to face the pandemic.
3.1 OVERVIEW OF THE BRAZILIAN HEALTH SYSTEM AND FOREIGN INVESTMENT ON HEALTH ASSISTANCE
Although there is no legal definition of the term “health assistance,” it is generally understood as the services rendered by public or private organizations for the promotion, protection and recovery of the human health.
Pursuant to Law No. 8,080/1990, the public actions and services addressed to the protection of human health are performed by federal, state and municipal public entities that shall ensure physical, mental and social welfare to the collectivity. Private entities may participate of the Brazilian Unified Health System (SUS) performing some complementary activities.
The Brazilian Constitution establishes that “the direct or indirect participation of foreign companies or capital in the Brazilian health assistance is forbidden, except in cases permitted by law” (section 199, 3rd paragraph).
Since 2015, when Law No. 13,097/2015 came into force, the direct or indirect participation, including control, of companies or foreign capital in health assistance has been allowed in the following cases (section 142): (i) donations from international organizations related to the United Nations, from technical cooperation entities and of financing and loans, (ii) legal entities intended to install, operate or explore (a) general hospitals, including philanthropic, specialized hospitals, polyclinics, general clinics and specialized clinics and (b) family planning actions and research and (iii) maintenance of health services by companies, for non-profit, in benefit of their employees and dependents, without any burden for social security.
3.2 HEALTH REGULATORY REQUIREMENTS
Since hospitals perform a broad scope of activities that may represent risks to the public health and to the environment, hospitals are subject to several requirements prior and during their regular operation, in order to attest that the carried-out activities follow the applicable legal standards.
In this sense, we list below the main requirements hospitals need to comply with in Brazil, according to the Brazilian legislation and regulation:
3.2.1 APPOINTING A TECHNICAL RESPONSIBLE AND MAKING SURE ALL PROFESSIONALS ARE REGULARIZED BEFORE THE COMPETENT PROFESSIONAL COUNCILS
Pursuant to Decree No. 20,931/1932, sections 24 and 28, public and private hospitals of any nature, as well as analysis, clinical trials labs, among other establishments performing healthcare activities are only allowed to operate if under the responsibility and the technical management of doctors or pharmacists, as applicable according to the activities performed.
As a result, hospitals must appoint a physician (which may be a partner of the company or not) to be the technical responsible of the establishment (“responsável técnico”). The technical responsible must be duly licensed by the Regional Medical Council (“CRM”) of the jurisdiction of the hospital.
After being duly appointed, the technical responsible must supervise and coordinate all medical services provided by the hospital (CFM Resolution No. 997/1980, section 11).
Other duties of the technical responsible are: (i) applying for the company’s registration before the CRM (CFM Resolution No. 997/1980, section 3, as explained in item 3.2.2. below), (ii) informing CRM of any modifications regarding their status as technical responsible, as well as of (iii) informing CRM of any modifications to the company’s bylaws and the changes to the hospital’s clinical staff every year.
Depending on the activities performed by the company, which should be described in the hospital’s internal procedures, it may be necessary to also obtain certifications and authorizations before others Class Entities.
Thus, other health professionals (e.g. nurses, physiotherapist, pharmacists) working in the hospital must also be registered at their corresponding professional councils, and the hospital must appoint a technical responsible for each of these areas, whenever applicable.
3.2.2 REGISTRATION of the entity BEFORE CRM AND OTHER PROFESSIONAL COUNCILS
Registration of the healthcare establishments and their branches, divisions and subsidiaries themselves before the CRM where they are located (as an entity) is mandatory, as determined by CFM Resolution No. 997/1980, section 2.
Such registration shall also be necessary before other applicable professional councils, depending on the other professionals who work at the hospital, as explained above.
3.2.3 OBTAINING SANITARY LICENSES
As stated before, ANVISA oversees activities and products considered “of health interest” in Brazil, therefore including the infrastructure of health assistance establishments and the operation of pharmacies and drugstores.
While ANVISA is the federal authority, state and municipal authorities are responsible for local inspections and supervision of compliance with both federal and local legislation and regulation, including for hospital activities.
Hospitals must obtain licenses from the corresponding local sanitary authority (State and/or Municipality, depending on the location), as provided by Decree No. 20,931/1932, section 24, along with other licenses required for their specific activities, which refer to the medical specialties and their internal facilities and regulation (e.g. ICU – Intensive Care Units, which are subject to rules by ANVISA, by the MoH and by the Professional Councils).
The legislation, regulation, necessary licenses and requirements are different from each State and Municipality. Thus, it is necessary to study the State and Municipality rules in which the hospital is/will be established considering its activities and internal facilities. With this information, the hospital can assess which are the applicable licenses, as well as the requirements and procedures to obtain such certifications.
In case the hospital outsources part of its activities, the outsourced companies must also have the necessary corresponding licenses, whenever applicable.
3.2.4 REGISTERING BEFORE THE National Database for Health Establishments (“CNES”)
All hospitals must also be registered with the CNES, a public database held by the MoH with the purpose of compiling general information of hospitals and medical clinics in the country, including performed activities and specialties, size, number of beds and employees.
Hospitals fit into the definition given by MoH Consolidation Ordinance No. 1/2017, section 360, II. A healthcare establishment is a “delimited and permanent physical space where human health actions and services are performed under technical responsibility”.
The purpose of CNES is the structuring and the preparation of public policies in healthcare. As explained in 3.1, private hospitals are also part of the Brazilian healthcare system as supplementary health establishments.
Therefore, registration before CNES is necessary prior to the health establishment’s operation and such enrollment needs to be frequently updated, as a condition to maintain operations.
3.2.5 OBTAINING ENVIRONMENTAL LICENSES
Federal Law No. 6,938/1981, which determines the National Environmental Policy, provides that effectively or potentially polluting activities need to be duly licensed by the competent State authorities before operating.
Considering that hospitals (i) provide different type of treatments, which may encompass dangerous substances; (ii) normally perform several complementary services such as drugstore, laundry, transports, cleaning, which also involve management of all sorts of substances that could pollute the environment; and (iii) use great amounts of water and energy to keep ongoing operations, it is necessary that they request to the authorities the necessary environmental licenses before the start of operations.
Specific environmental licenses that allow the hospital’s operation must also be maintained and renewed.
3.2.6 OBTAINING A FIRE DEPARTMENT INSPECTION CERTIFICATE
All establishments need to be inspected by the local Fire Department and be granted the corresponding certificate that prove the installations are compliant with the local regulation to prevent fires. This certification considers the capacity of the building to hold a certain number of people, the presence of emergency exists and strategic positioning of fire extinguishers, etc.
This is also applicable to hospitals, which need to observe the regulation set by the State where it is located.
3.2.7 REGULARIZATION OF PHARMACIES AND DRUGSTORES
In Brazil, pharmacies and drugstores are subject to: (i) Federal health legislation; (ii) regulations issued by ANVISA; (iii) state and municipal (local) legislation; and (iv) regulation and ethical standards provided by the Federal Council of Pharmacy (“CFF”).
Federal health legislation sets that drugstores need to have permits and licenses for operation (Federal Law 13,021/2014, Section 6), which are operating permit (AFE) and a special permit (AE), the latter due to controlled drugs or substances, as issued by ANVISA pursuant to ANVISA Resolution No. 275/2019, as well as local sanitary license.
Furthermore, the drugstore or drug dispensary should be registered with the Regional Council of Pharmacy where it is located (“CRF”), as well as have a technical responsible duly registered at such CRF, pursuant to CFF Resolution No. 638/2017, section 43 and beyond.
If the activities of the drugstore or the drug dispensary involve controlled drugs or substances, besides from obtaining an AE before ANVISA, additional licenses before the Civilian Police and Brazilian Army, for example, may be necessary depending on the relevant substances or drugs.
3.2.8 OBTAINING APPROVAL FOR THE HOSPITAL BASIC ARCHITECTURAL PROJECT
Prior to construction, expansion, renovation and/or adaptation, all health facilities need to have the corresponding Basic Architectural Project (“BAP”), approved by the local sanitary surveillance authorities.
ANVISA Resolution No. 51/2011 and ANVISA Resolution No. 50/2002 list the technical requirements to the BAP regarding architectural and engineering standards and determine that the BAP needs to be filed at the competent State or Municipality authorities, depending on the location, for the emission of a technical opinion.
The construction, expansion, renovation or adaptation shall be carried out in accordance with the BAP as approved by the authorities. At the end of the construction/adjustments, the person responsible for the execution and the legal representative of the healthcare facility need to sign a Liability Term claiming that the construction was carried out in compliance with the BAP. The sanitary surveillance authorities can make inspections at any time in order to check these measures
|Marco Aurélio Torronteguy
Office: São Paulo
E-mail: [email protected]
Tel.: (55 11) 5086-5298
Life Sciences & Healthcare
Partner in TozziniFreires Life Sciences and Healthcare practice group, Marco Aurélio has broad experience in regulatory matters and administrative health regulatory proceedings. He assists clients in several sectors of the industry, besides assisting health service providers. He also acts in regulatory consulting and administrative proceedings, especially before ANVISA (Brazilian Health Regulatory Agency) and MAPA (Brazilian Ministry of Agriculture, Livestock and Food Supply), as well as in matters involving the licensing and registration of products subject to health surveillance, new technologies, the launch of new products in the Brazilian market and drug recall.
- Doctor of Laws from USP (Universidade de São Paulo), 2010.
- Specialized degree in Health Law from USP, 2010.
- Master’s degree from UFSM (Universidade Federal de Santa Maria), 2006.
- Graduate of the Law School of UFSM, 2003.
- Former Vice-Chair of the Health Law Committee of OAB/SP (Brazilian Bar Association, São Paulo section).
- Former Counselor at the CNS (National Health Council), 2nd Alternate, representing MOPEM (Multiple Sclerosis Movement).
Recommended by legal guides Chambers Latin America and Leaders League.
- “Brazil” chapter (co-author). In The Life Sciences Law Review. London: Law Business Research, 2016.
- “Brazil” chapter (co-author). In Chambers Global Practice Guides – Life Sciences. London: Chambers & Partners Publishing, 2015.
- “Brazil” chapter (co-author). In Getting the Deal Through – Life Sciences. London: Law Business Research, 2014.
- Several articles in national and international publications.
 Available at https://www.ibanet.org/unit/Law+and+Individual+Rights+Section/committee/Healthcare+and+Life+Sciences+Law+Committee/3089. Access on September 13, 2021.
 Federal Law No. 8,080/1990, section 6, first paragraph.
 Federal Law No. 9,782/1999, section 6.
 Federal Law No. 6,360/1976, section 50: The company’s operation to which this Law regards shall depend on an authorization granted by ANVISA, after the requirement for enrollment of their activities, payment pf the corresponding Sanitary Surveillance Inspection Fee and other requirements set by specific ANVISA regulations.
 ANVISA Resolution No. 16/2014, section 3.
 Federal Law No. 6,360/1976, sections 51 and 52.
 Law-Decree No. 986/1969, section 46.
 ANVISA Resolution No. 16/2014, section 27, II, “b”.
 ANVISA Resolution No. 16/2014, section 27, II, “e”.
 Federal Law No. 6,360/1976, section 25.
 Decree-Law No. 986/1969, section 3.
 As provided by ANVISA Resolutions No. 27/2010 (modified by ANVISA Resolutions No. 240/2018, No. 319/2019, and No. 460/2020) and No. 23/2000 (partially revoked by ANVISA Resolutions No. 278/2005 and No. 27/2010).
Available at: https://www.fda.gov/media/90179/download?source=govdelivery&utm_medium=email&utm_source=govdelivery. Access on September 13, 2021.
 Whichever product that is not a drug, nor a cosmetic or a sanitizing product, is a health product.
 Modified by ANVISA Resolutions No. 387/2020 and 425/2020.
 Modified by ANVISA Resolution No. 422/2020.
 Modified by ANVISA Resolutions No. 498/2021, No. 496/2021, No. 516/2021, No. 531/2021, No. 561/2021.
 Modified by ANVISA Resolution No. 32/2018.