1. INTRODUCTION
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, including the newest trends in the sector.
2. 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 issues caused by the environment, the production 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 a company that performs activities of health interest (that is, that can cause damage to health) to be granted several permissions by the public power to operate.
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 involved. Thus, references below should be adapted to each specific situation.
1Available at https://www.ibanet.org/unit/Law+and+Individual+Rights+Section/committee/Healthcare+and+Life+Sciences+Law+Committee/3089. Access on September 13, 2021.
2Federal Law No. 8,080/1990, section 6, first paragraph.
3Federal Law No. 9,782/1999, section 6.
2.2. MAIN SANITARY REQUIREMENTS
2.2.1. COMPANY’S OPERATION PERMITS
The permission for private entities to operate, on a federal level4, with products subject to sanitary surveillance corresponds to the Operation Permit (“AFE”), necessary to establishments that perform storage, distribution, packing, expedition, exportation, extraction, manufacturing, fractioning, importation, production, purification, repacking, synthesis, transformation and transport activities of drugs and pharmaceutical inputs intended for human use, cosmetics, products for personal hygiene, perfumes, household sanitizers and packing of medical gases5. Even though food is subject to sanitary surveillance, food industries and service renderers are exempt from obtaining an AFE.
If the establishment also handles controlled substances or controlled drugs, as set by MoH Ordinance No. 344/1998, it is necessary to obtain a Special Authorization (AE) before Anvisa6. Licenses before the Federal Police, the Civil Police or the Brazilian Army may be necessary depending on the handled substances.
On a local level, i.e. state and or municipal level, the licensing7 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 case8.
Moreover, depending on the performed activities, it may be necessary to enroll the establishment before a regional professional council (e.g. Chemistry, Pharmacy, Engineering Council etc.) and to appoint a technical responsible party, that will be responsible for the regulated activities performed at the establishment9.
The reason of the need for previous approval of the establishment by the authorities is the 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 system10, hygiene conditions, storage and operation suit to the product’s needs, so as to reduce the contamination risk, risk of altering its characteristics, etc11.
4Federal 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 enrolment of their activities, payment pf the corresponding Sanitary Surveillance Inspection Fee and other requirements set by specific Anvisa regulations.
5Anvisa Resolution No. 16/2014, section 3.
6Anvisa Resolution No. 16/2014, section 4.
7Federal Law No. 6,360/1976, sections 51 and 52.
8Law-Decree No. 986/1969, section 46.
9Federal Law No. 6,360/1976, section 8.
10Anvisa Resolution No. 16/2014, section 27, II, “b”.
11Anvisa Resolution No. 16/2014, section 27, II, “b”.
2.2.2. MARKETING AUTHORIZATIONS: REGISTER AND NOTIFICATION
As to products of health interest and, therefore, subject to health surveillance: drugs, pharmaceutical inputs, medical devices, products for personal hygiene, perfumes, cosmetics, household sanitizers, products for esthetic purposes12, among others, are subject to register or notification before Anvisa, depending on the risk they represent.
They are 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. on drugs, medical devices, cosmetics).
Some food products may also be subject to registration with Anvisa, such as formulae for enteral nutrition, food for children13. New food and new ingredients are subject to authorization for use14. However, food products are normally exempt from registration and are subject only to a communication to local sanitary authorities prior to manufacturing15.
12Federal Law No. 6,360/1976, section 25.
13Decree-Law No. 986/1969, section 3. Anvisa Resolution No. 27/2010, Annex II.
14Anvisa Resolution No. 839/2023.
15As 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).
2.2.3. CERTIFICATION OF GOOD MANUFACTURING PRATICES (GMP CERTIFICATE)
Depending on the potential risk to health, a specific certification is necessary for the manufacturing of certain products (such as drugs, active pharmaceutical inputs and high-risk medical devices), as granted by Anvisa, attesting that the manufacturing facility complies with Good Manufacturing Practices (“GMP”).
In order to obtain this Certification of Good Manufacturing Practices (“GMPc”), Anvisa inspects the company’s manufacturing facility to check if the technical regulation with regard to the GMP of such product is totally complied with. Inspection to certify GMP in establishments located in Brazil can also be carried out by the local health surveillance (of the corresponding State or Municipality).
In the case of imported products, Anvisa usually travels to manufacturing sites abroad. Even though several countries demand a GMPc, 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.
Anvisa has been accepting reports and opinions issued by international entities in certain situations. 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, it may be subject to a single local audit, which shall be valid in Brazil, that is, Anvisa would not need to inspect the manufacturing facility.
Indeed, current norm on obtention or renewal of GMPc for medical devices establish special criteria due to MDSAP, Mercosur system and International Medical Device Regulators Forum (IMDRF).
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 GMP of drugs for human or veterinary use.
In August 2022, Resolution Anvisa Np. 741/2022 was published, extending the possibility of applying international validation mechanisms to all product categories, subject to the publication of specific norms on each case.
For instance, medical devices of risk classes III and IV are subject to Anvisa Normative Instruction (“NI”) No. 290/2024; Anvisa NI No. 289/2024 regulates the register and post-register procedures applicable to drugs, biological products, vaccines and to adequation letter for active pharmaceutical input dossier (Cadifa); and Anvisa NI No. 292/2024 establishes the optimized procedure for the granting of GMPc based on inspection reports and documentation issued by Equivalent Foreign Regulatory Authorities (AREEs).
Even so, Anvisa is still the competent authority to grant GMPc to manufacturers of products in the Brazilian market.
The GMPc is applicable to most industries of products of health interest, but normally it is not a mandatory license, as described above. However, several rules establishing GMP exist in connection to different products with which industries and service providers need to comply with.
16Available at: https://www.fda.gov/media/90179/download?source=govdelivery&utm_medium=email&utm_source=govdelivery. Access on September 13, 2021.
17Anvisa Resolution No. 687/2022.
18Such Resolution also sets that other regulatory reliance measures can be adopted, as established by specific rules, including by means of regulatory harmonization and convergence measures, agreed upon and implemented by foreign authorities; as well as that documentation arising from multilateral organizations, international institutions or third party organisms can be used, pursuant to guidelines and rules on specific programs and mechanisms Anvisa is a part of.
2.2.4. DEFINITION OF PRICES OF DRUGS BY CMED
To be commercialized in Brazil, a drug must have its maximum price approved by the Chamber for Drug Market Regulation (“CMED”). CMED is the federal authority in charge of the economic regulation of the drug market and for the definition of criteria for setting and adjusting the prices of drugs19.
The marketing authorization holder must submit to CMED a price information document for each new drug or new presentation20.
The companies are responsible for complying with the maximum prices approved by CMED. Non-compliance with CMED rules subject the company to the administrative penalties of the Consumerist Code21.
In March 2021, Anvisa issued a Resolution regarding the economic monitoring of medical devices strategic to public health. Through this rule, Anvisa aims to contribute to the reduction of asymmetry of information in the market of medical devices, by providing the statistics of the historical prices of the products22. The result of this monitoring may be used as a price benchmark for public or private purchases of medical devices23.
2.3. NEW PRODUCTS AND GUIDELINES
Brazilian regulation on sanitary surveillance is very broad and, as products and technology evolve, authorities have been regulating new matters. We have listed below some of the trends and latest matters in connection with sanitary surveillance in Brazil.
19Federal Law No. 10,742/2003, section 6, I and II.
20Federal Law No. 10,742/2003, section 7.
21Federal Law No. 10,742/2003, section 8, and Federal Law No. 8,078/1990, section 56.
22Resolution Anvisa No. 478/2021, section 4, I.
23Resolution Anvisa No. 478/2021, section 8.
2.3.1. NEW RULES ON CLINICAL RESEARCH
Federal Law No. 14,874/2024 has been published. It now disciplines, at a federal level, research involving human beings, which must meet ethical and scientific requirements, as regulated before by the National Council of Health (CNS) Resolution No. 466/2012. The market still waits further regulation of the matter.
2.3.2. DIGITAL PACKAGE INSERTS
Anvisa Resolution No. 885/2024 establishes the guidelines for the pilot project for the implementation of the digital package insert, a significant innovation for the market. Initially, the digital package insert may only be used for medications (i) in sample packaging; (ii) intended for use in healthcare facilities – excluding pharmacies and drugstores; (iii) with government allocation, contained in packaging with distinctive elements of the MoH; and (iv) exempt from prescription, packaged in multiple containers.
2.3.3. NATIONAL PRESCRIPTION CONTROL SYSTEM
Anvisa Resolution No. 873/2024, which came into effect on July 18, 2024, created the National Prescription Control System (SNCR) and determined that prescription control will be conducted through an online platform to be made available by Anvisa to local health surveillance authorities.
The platform will provide the numbering that must be used in prescription notifications by prescribers to prevent fraud or forgery of prescriptions. Starting in 2025, the use of the platform will be mandatory, without prejudice to the possibility of its use in 2024.
2.3.4. PAINTS AND VARNISHES WITH SANITIZING ACTION
In April 2024, Anvisa Resolution No. 847/2024 came into effect, which establishes the technical requirements for the regulation of paints and varnishes for real estate use with sanitizing action. Since 2011, Anvisa has received requests for the regulation of these products; however, there was no specific procedure formalized.
Now, it is established that paints and varnishes for real estate use with antimicrobial sanitizing action (disinfectant or sanitizer) or with pest control sanitizing action (insecticide or repellent), available for free sale and restricted sale to specialized companies, are sanitizing products classified as risk level 2. Therefore, they are subject to sanitary registration in accordance with Anvisa Resolution No. 59/2010 and must have their residual efficacy demonstrated.
3. HEALTHCARE
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 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 in the Brazilian Unified Health System (SUS) performing 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 for cases permitted by law”24.
Since 2015, when Federal 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 cases25: (i) donations from international organizations related to the United Nations, from technical cooperation entities and of financing and loans, (ii) legal entities intended to implement, 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 purposes, in benefit of their employees and dependents, without any burden for social security.
24Brazilian Constitution, section 199, third paragraph.
25Federal Law No. 13,097/2015, section 142.
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, such establishments are subject to several requirements prior and during their regular operation, in order to attest that the activities carried out 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 PARTY AND MAKING SURE ALL PROFESSIONALS ARE REGULARIZED BEFORE THE COMPETENT PROFESSIONAL COUNCILS
Pursuant to Federal Decree No. 20,931/193226, public and private hospitals of any nature, as well as analyses and clinical trials laboratories, among other establishments performing healthcare activities, are only allowed to operate if under the responsibility and the technical management of physicians or pharmacists, as applicable, depending on the activities performed.
As a result, hospitals must appoint a physician to be the technical responsible party for the establishment (responsável técnico). The technical responsible must be duly licensed by the Regional Medical Council (“CRM”) of the jurisdiction of the hospital27.
After being duly appointed, the technical responsible must supervise and coordinate all medical services provided by the hospital.
Other duties of the technical responsible are: (i) applying for the company’s registration before the CRM (as explained in item 3.2.2. below)28, (ii) informing CRM of any modifications regarding their status as technical responsible party, 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 councils.
Thus, other healthcare professionals (e.g. nurses, physiotherapists, pharmacists) working at 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.
26Decree No. 20,931/1932, sections 24 and 28.
27CFM Resolution No. 997/1980, section 11.
28CFM Resolution No. 997/1980, section 3.
3.2.2. REGISTRATION of the entity BEFORE CRM AND OTHER PROFESSIONAL COUNCILS
Registration of the healthcare establishments and their branches, divisions, and subsidiaries before the CRM where they are located (as legal entities) is mandatory29.
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, sanitary surveillance 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.
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)30, 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 the hospital is/will be subject to, 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 authorizations.
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: 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.
29CFM Resolution No. 997/1980, section 2.
30Decree No. 20,931/1932, section 24.
3.2.5. OBTAINING ENVIRONMENTAL LICENSES
Federal Law No. 6,938/198132, which establishes 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 types of treatments, which may encompass dangerous substances; (ii) normally perform several complementary services such as drugstore, laundry, transport, 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 operations going, it is necessary that hospitals request to the authorities the necessary environmental licenses before starting 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.
31MoH Consolidation Ordinance No. 1/2017, section 360, II.
32Regulated by IBAMA NI No. 13/2022.
3.2.7. TELEHEALTH
Remote rendering of health services is, currently, regulated by Federal Law No. 14,510/2022. The express mention to this model by the Brazilian legislation derives from the normative evolution caused by the Covid-19 pandemic, starting on 2020.
Even though telehealth today encompasses the remote rendering of services by all healthcare professions regulated by the federal Executive Power34, it is NOTEWORTHY that in the beginning of 2020, only CFM Resolution No. 1,643/2002 regulated the matter, as PREVIOUSLY applicable only to the practice of medicine. Besides, the norm only regulated telemedicine as INTERACTION BETWEEN physicians, not involving patients.
With Covid-19 came the need to avoid in-person medical consultations so as to avoid unnecessary exposure to possible infections. Thus, MoH Ordinance No. 467/2020 and, later on, Federal Law No. 13,989/2020 authorized the use of telemedicine during the Covid-19 pandemic until the end of the corresponding Public Health Emergency of National Importance (“ESPIN”).
In 2022, before the end of the ESPIN, CFM Resolution No. 2,314/2022 came into force, revoking CFM Resolution No. 1,643/2002. Therefore, today remote medical consultations between physicians and patients are allowed both synchronously (in real time) and asynchronously (offline).
Finally, after the publication of Federal Law No. 14,510/2022, the practice of telehealth throughout the national territory was definitively authorized. Thus, not only the practice of telemedicine has been allowed, but also the practice of other health services that had been regulated only during the Covid-19 pandemic, such as remote consultations with psychologists, nutritionists, speech therapists, among others.
It is important that people interested in rendering telehealth services inform themselves about the applicable requirements, as detailed in the regulation issued by each competent professional council.
3.2.8. 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 operation35, 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 party duly registered at such CRF.
33Federal Law No. 14,510/2022 has amended Federal Law No. 8,080/1990, which sets the conditions for the promotion, protection and recovery of health, the organization and operation of corresponding services, among other matters.
34Federal Law No. 8,080/1990, section 26-A.
35Federal Law 13,021/2014, Section 6.
3.2.9. 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 issuance of a technical opinion.
The construction, expansion, renovation, or adaptation must be carried out in accordance with the BAP as approved by the authorities. At the end of the construction/renovation, the person responsible for carrying it out and the legal representative of the healthcare facility need to sign a Liability Term claiming that the construction has been carried out in compliance with the BAP. Sanitary surveillance authorities can make inspections at any time in order to check these measures.
Authors: Marcio Mello Baptista e Bárbara Bassani de Souza
TozziniFreire Advogados
Rua Borges Lagoa, 1328
04038-904 – São Paulo – SP
Phone: (11) 5086 5000
Fax: (11) 5086 5555
E-mail: [email protected]
Internet: www.tozzinifreire.com.br
Partner in TozziniFreire’s Life Sciences and Healthcare practice group and Doctor of Laws from USP (Universidade de São Paulo), 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.