Check out our monthly Life Sciences Newsletter, which gathers information about recent legislation, news, public consultations, and bills concerning the health and agriculture sectors in Brazil.
For more information, please contact our lawyers.
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Demarest’s Life Sciences Team
ANVISA – National Health Regulatory Agency
Cannabis research and cultivation encouraged by ANVISA
On December 08, 2022, the Collegiate Board of ANVISA authorized the cultivation of Cannabis at Universidade Federal do Rio Grande do Norte (Rio Grande do Norte State University), solely for the research of effects from cannabis-derived products.
The Collegiate Board analyzed safety and control matters in order to carry out cannabis studies, and established the requirement that ANVISA be informed and monitor all such studies. It is worth highlighting that this is the first time ANVISA authorizes in loco cannabis cultivation in Brazil, given that all existing permissions were granted by the judiciary branch.
The decision can be read in full here.
State of São Paulo passes Bill ensuring the dispensing of Cannabis Products by SUS
On December 21, 2022, the State Legislature of São Paulo passed Bill No. 1,180/2019, which established a state policy providing for the dispensing of cannabidiol plant-based medicines, free of charge, in public and private health establishments of the Brazilian Unified Health System (“SUS”).
Given the lack of federal laws regulating the matter, states have the competence to establish laws that improve the access of the population to Cannabis Products. The Bill is pending approval by the governor of the state of São Paulo.
ANVISA – National Health Regulatory Agency
New regulatory framework changes medicine labeling rules
In December 2022, ANVISA published five rules that provide for the labeling of medicines:
- RDC No. 768/2022: provides for medicine labeling rules in general.
- Normative Instruction No. 198/2022: establishes specific requirements for the labeling of high and low volume parenteral solutions, sterile irrigation solutions, dyalisis and plasma expanders.
- Normative Instruction No. 199/2022: establishes the list of active pharmaceutical inputs whose name is phonetically or visually similar to other inputs.
- RDC No. 770/2022: establishes warning labels for substances, therapeutic classifications and control lists in medication direction leaflets and packages.
- Normative Instruction No. 200/2022: establishes substances, therapeutic classifications and control lists that require warning labels indicating its presence in medicines – whether as active ingredient or excipient –, and defines the wording of such warnings.
The rules above review RDCs No. 71/2009 and 137/2003,, and the drafting of the new requirements was influenced by the need to protect the patient’s rights and safety when buying and consuming medicines. Within the same context, RDC No. 769/2022 was published, establishing rules for medication direction leaflets.
Among the main highlights are:
i. prohibition from printing information on low volume parenteral solutions;
ii. adoption of the Tall Man Lettering technique to differentiate active ingredients whose names are phonetically or visually similar; and
iii. inclusion of the ANVISA logo next to the registration number.
Pharmaceutical companies will have 24 months to adapt to the new rules, which will enter into force 180 days following their respective publication.
ANVISA – National Health Regulatory Agency
New resolution updates rules regarding egg donor banks
On December 28, 2022, RDC No. 771/2022 was published, providing for Good Practices in the therapeutic use of Germ Cells, Germ Lawyers and Human Embryos, among other provisions within the same scope. The rule amends RDC No. 23/2011 and will enter into force on February 01, 2023.
Due to the exponential growth in demand and supply for assisted reproduction procedures, ANVISA changed the regulation to ensure better control and quality in the import of gametes and embryos, as well as a more thorough health analysis by ANVISA.
It is worth highlighting that the previous wording of the resolution only provided for activities within the scope of embryo and gamete donor banks, such as the processing, storage and transport of such material, while import was exclusively provided for in RDC No. 81/2008.
ANS – Brazilian Supplementary Healthcare Agency
Updated rules on the regulatory capital of health care plan operators
On December 23, 2022, Normative Resolution No. 569/2022 was published, introducing new rules regarding the definition of regulatory capital for health care plan operators, and repealing NRs No. 526/2022 and 514/2022, in addition to partially amending Normative Resolution No. 515/2022.
The new rules, which had been the subject of Public Consultation No. 102/2022, entered into force on January 01, 2023. As a result, solvency matters of health care plan operators will now be addressed according to a risk-based capital system.
The goal is to prevent the interruption of health care operators’ activities and ensure more security to such companies, as well as to the beneficiaries.
ANS – Brazilian Supplementary Healthcare Agency
Resolution establishes criteria for EEPC operations within the market of private health care plans
On December 07, 2022, Resolution No. 552/2022, was published, which establishes rules providing for the legal responsibilities of ANS and the Brazilian National Superintendence of Supplementary Private Pension (“PREVIC”) in regard to private health care plans managed by Closed Supplementary Private Pension Entities (“EEPCs” or “private pension funds”).
The new regulation establishes individual and joint responsibilities of ANS and PREVIC in regard to the activities of health care plan operators, in addition to requirements for the operation of EEPCs in the private health care plan market.
ANS – Brazilian Supplementary Healthcare Agency
Normative Resolution establishes proceedings to update ANS List of Health Procedures and Events
On December 16, 2022, NR No. 555/2022 was published, which provides for the process of updating the list of mandatory health procedures and events of ANS in Brazilian territory.
The rule established deadlines to:
- carry out a technical evaluation of proposals to update the list of eligible health events and procedures; and
- define professionals and respective responsibilities in the Committee for Updating the List of Health Events and Procedures in Supplementary Health (COSAÚDE), which will assist ANS in the technical evaluation of the proposals.
ANS – Brazilian Supplementary Healthcare Agency
Repeal of ANS rules changes regulatory structure of supplementary healthcare
On December 30, 2022, ANS published ten Resolutions and four Normative Instructions, which will be effective from February 01, 2023 and will repeal several old rules.
The main changes involve the contracting of an individual microbusiness plan, prohibition of direct billing of beneficiaries of a group plan, and the event of exclusion of a beneficiary from the group plan. Below are the main changes:
i. NR No. 557/2022: regulates the classification and characteristics of private health care plans and their contracting, and provides for the contracting of a collective corporate private health care plan by an Individual Business Owner. Consequently, the rule has repealed Resolutions and Instructions No. 195/2009, 200/2009, 204/2009, 260/2011, 432/2017, 455/2020, and 20/2009;
ii. NR No. 561/2022: regulates the cancellation of an individual or family health plan contract, as well as the exclusion of a beneficiary from a corporate or adhesion collective contract. The rule repealed NR No. 412/2016.
iii. NR No. 563/2022: establishes the limits to be followed for the adoption of price variation by age bracket in contracted private health care plans, mainly repealing NR No. 63/2003;
iv. NR no. 565/2022: establishes the conditions for the application of readjustment of the monetary installments for private plans of supplementary health care, medical-hospital plans, with or without dental coverage, and of exclusively dental private plans of supplementary health care, contracted by individuals or legal entities. The following Resolutions were repealed: 171/2008, 172/2008, 309/2012, 362/2014, and NR No. 274/2011 was amended;
v. NR No. 29/2022: regulates the communication procedures of readjustments of monetary installments for private plans of supplementary health care, contracted by legal entities, regardless of sector and date of contracting. The rule repealed Instructions No. 13/2006, and 47/2014.
MS – Brazilian Ministry of Health
Telehealth law sanctioned by Brazilian President
On December 28, 2022, Law No. 14,510/2022, which authorizes telehealth services in Brazil and amends the Organic Health Law.
The new law aims to provide more legal certainty to companies of the sector, given that the matter lacked regulation since the Covid-19 pandemic.
Telehealth practices must be carried out under the principles of professional autonomy and patient informed consent.
Access our Client Alert to find out more about the topic.
MS – Brazilian Ministry of Health
Nursing wage floor Constitutional Amendment approved by National Congress
On December 22, 2022, Constitutional Amendment No. 127/2022 (“EC”) was published, which establishes the federal government’s responsibility of providing financial assistance to Brazilian states and municipalities in paying the nursing wage floor provided for by Law No. 14,434/2022 and EC No. 124/2022.
The new EC is an additional legal instrument that seeks to ensure that the nursing wage floor is covered by the Brazilian Unified Health System (“SUS”). It is worth highlighting that the Supreme Federal Court had previously suspended the nursing wage floor law due to lack of funding.
MAPA – Ministry Of Agriculture, Livestock and Food Supply
Bioinput Bill advances in the House of Representatives
Bill No. 658/2021, which regulates the production of bioinputs for agriculture in Brazil, was approved by the Commission for Constitution and Justice and Citizenship of the House of Representatives. Currently, the lack of specific regulation providing for such production is prejudicial to the agriculture sector.
Consequently, the purpose of the Bill is to ensure that the entire process of producing, trading and using bioinputs in agriculture be regulated under the new rule, in order to increase soil productivity and fertility, as well as prevent the spread of pests and plant diseases in crops.
The Bill adds force to other measures in motion to implement the use of bioinputs in agriculture, especially in order to establish an alternative method to conventional pesticides.
MAPA – Ministry Of Agriculture, Livestock and Food Supply
New law establishes self-monitoring farming system
On December 30, 2022, Law No. 14,515/2022 was published, which provides for:
- self-monitoring systems of private agents regulated by the defense of agriculture and livestock raising; and
- the structuring and procedures carried out by the defense of agriculture and livestock raising in regard to production chains of the farming sector.
The proposal transfers monitoring responsibilities to individuals or legal entities, who must assess technical information and inform the authorities of the defense of agriculture and livestock. Such individuals or legal entities can be accredited by MAPA and other public bodies that belong to the Unified System for Farming and Cattle Health (SUSASA).
The new monitoring system resulted in diverging opinions. Certain representative bodies trust that the change will render monitoring activities more effective, while others believe it will decrease the quality of technical requirements.
MAPA – Ministry Of Agriculture, Livestock and Food Supply
Seed trade regulated by MAPA
On December 23, 2022, Ordinance No. 538/2022 was published, which consolidated rules providing for all the requirements for the production process, trading and use of seeds. The rule will enter into force on March 01, 2023.
The Ordinance establishes obligations for producers, such as:
- registration of seeds in the National Registry of Cultivars (RNC); and
- certification of the seeds, issued by an accredited entity of the National Registry of Seeds and Seedlings (RENSAEM) or by MAPA.
The trading of seeds must comply with requirements of storage and identification of the products, especially in regard to genetic background and production location, in addition to obtaining declarations of conformity with the respective class and category of the product.
MAPA – Ministry Of Agriculture, Livestock and Food Supply
New rule provides for beef production
On December 26, 2022, Ordinance No. 723/2022 was published, which provides for minimum requirements of identification and quality to produce aging beef. The regulation approved by MAPA provides for the appropriate naming of products for sale, taking the classification of beef cuts into consideration.
The main purpose of the Ordinance is to standardize the process of beef production. Among the main highlights are:
- mandatory storage of the beef cut in vacuum packaging, using appropriate materials;
- maximum aging temperature as well as storage conditions; and
- inclusion of information regarding the aging period and expiration date on package labels.
Establishments will have one year to adjust to the new requirements.
MAPA – Ministry Of Agriculture, Livestock and Food Supply
Ordinance establishes specific criteria to produce hamburgers
On December 26, 2022, Ordinance No. 724/2022 was published which established standards of identification and quality for the production of hamburgers.
MAPA defined hamburger as “the meat-based produced obtained through the grinding of animal meat, with or without added fat and ingredients, molded in a disk or oval shape and processed through the appropriate technology”.
Among the main highlights of the Ordinance are:
- Provision that the name of a certain cut of meat can only be advertised in the package if the product is 100% based from such cut.
- Hamburgers produced from more than one type of animal meat must specify such information on the package label.
- Producers are responsible for the appropriate packaging and storage of the product.
It is worth highlighting that the Ordinance does not provide for the use of plant-based “meat”, a topic that has been consistently discussed by consumers and companies of the sector.
Establishments will have one year to adjust to the new requirements.
MAPA – Ministry Of Agriculture, Livestock and Food Supply
Identification and quality criteria established for production of cane spirits and cachaça
On December 27, 2022, Ordinance No. 539/2022 was published, which provides for requirements to product cane spirits and cachaça. The goal is to standardize the production process so that the quality of the final product is compatible with the marketing name of such product.
Among the criteria analyzed by MAPA are:
i. alcohol content;
ii. production temperature;
iii. use of appropriate bottles or containers according criteria established for aging procedures;
iv. sugar content;
v. labeling;
vi. mandatory ingredients; and
vii. production process.
The provisions of the Ordinance seek to ensure that such spirits conform to a high quality standard, prohibiting the use of raw materials or the carrying out of procedures that can jeopardize the consumers’ well-being.
]PUBLIC CONSULTATIONS AND HEARINGS:
ANVISA – National Health Regulatory Agency
Proposal analyzes definition of Foreign Regulating Authorities for optimized procedures
On December 28, 2022, ANVISA opened a Public Consultation to collect contributions regarding a proposed rule that regulates specific criteria and procedures for the definition of Equivalent Foreign Regulating Authorities (“AREE”) involved in the health oversight process of active pharmaceutical inputs, medicinal Cannabis Products, medicines and bioproducts.
Such proposal results from RDC No. 741/2022, which establishes the possibility of carrying out optimized regularization procedures through registries and opinions issued by AREEs. As a result, ANVISA can analyze requests more quickly.
Contributions can be submitted by March 06, 2023.
ANVISA – National Health Regulatory Agency
Public Consultation addresses procedures of registration and post-registration of medicines
ANVISA opened a Public Consultation to analyze a proposal for the implementation of an optimized medicine assessment procedure based on risk criteria, and to verify compliance of such procedure with health requirements of the documentation submitted in registration claims and post-registration amendments.
The proposal aims to adjust such procedures in order to ensure that approved medicines conform to standards of high quality, safety and efficacy for the population. ANVISA will also analyze the risks of the product, in addition to all information and documents submitted.
Contributions can be submitted by March 06, 2023.
MAPA – Ministry Of Agriculture, Livestock and Food Supply
Public Consultation addresses proposal to establish health criteria on the import of animals from Mercosul countries
On December 23, 2022, a Public Consultation was opened to obtain contributions regarding a proposal to consolidate health oversight criteria on the import of animals from Mercosul Countries.
The proposal aims to acknowledge the status of the animals, the genetic material and other animal-based products of the exporting location, especially in regard to the origin of diseases, according to the following criteria:
1. Diseases whose country of origin is officially recognized by the World Organization for Animal Health: official recognition by the Mercosul country is automatic.
2. Diseases whose criteria of the country of origin are listed in the Terrestrial Animal Health Code of the World Organization for Animal Health: recognition by the Mercosul country must be preceded by an analysis of compliance with existing international requirements.
3. Diseases whose criteria of the country of original is not listed in the Terrestrial Animal Health Code of the World Organization for Animal Health: subject to previous evaluation of the health situation of the location.
The proposal is essential to ensure the integration of Mercosul countries in regard to the health safety within the process of importing animals. It is worth highlighting that such proposal does not seek to limit the autonomy of Veterinarian Authorities in each country regarding the carrying out of their own assessment of the exporting country.
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