[vc_row][vc_column][vc_column_text]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.
Enjoy your reading!
Demarest’s Life Sciences Team[/vc_column_text][vc_empty_space height=”40px”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Agenda of Regulatory Results Analysis is disclosed
On August 09, 2022, the Brazilian National Health Regulatory Agency (“ANVISA”) published the Agenda of Regulatory Results Analysis (“ARR”) for normative acts published in 2021 and 2022.
The ARR comprises a study carried out by the Agency to assess the practical effects arising from the publication of a normative act with wide repercussions in the country, which has a great economic impact or that has presented eventual problems resulting from its application. In this way, the practical perspectives of the market and society are considered because of the application of such normative act.
The planning carried out by ANVISA results from Decree 10,411/2021 which establishes that it will be mandatory and must be completed by December 31, 2022. Six Collegiate Board Resolutions (“RDC”) involving health products, medications and imported products were selected and can be found on the official website of ANVISA.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Practical and normative effects of food donation are evaluated by ANVISA
On August 09, 2022, the Regulatory Impact Analysis (“RIA”) report about the regulation of food donation was released. ANVISA’s Collegiate Board chose to adopt a non-normative measure to resolve the issue.
The RIA consists of a procedure prior to the publication of a normative act by the Agency. The information and data of the likely effects from the publication of a normative act are assessed, to verify the relevance of the topic and define which measure will be implemented.
The conclusion of the AIR report defined that ANVISA will not regulate the matter of health safety for food donation, but will adopt an alternative measure through the publication of an Instruction Guide in line with Law No. 14,016/2020, which provides for prevention of food waste and food donation.
The initiative will be important for companies in the food sector, which will be able to adopt the correct procedures for donating surplus food, avoiding possible inspection fines. The full report is available on the official ANVISA website.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
State of Alagoas analyzes the approval of a Bill authorizing the use of medicinal Cannabis
The Bill that authorizes the use of medicinal Cannabis in the state of Alagoas was preliminarily approved by the House of Representatives. The proposal aims guarantee the population’s access to the cannabis-based medicine.
Currently, the use of medicines derived from cannabidiol is allowed, as long as there is a previous authorization from ANVISA. The topic still lacks regulation at the state level, since this therapeutic methodology is still a novelty in Brazil. Therefore, it is likely that other states will publish legislations in this direction.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Cannabis cultivation on-site is authorized by the judiciary
By a trial ruling, the Federal Court of Rio de Janeiro authorized the cultivation of Cannabis Sativa destined to extraction of oil for personal and medicinal use, as well as the import of seeds.
Here, the plaintiff suffers from pityriasis lichenoides (a skin condition characterized by small, raised pink spots that tend to come together in groups), and other chronic diseases, and the most appropriate treatment so far is carried out through medicinal Cannabis.
Note that the Superior Court of Justice has already ruled on the subject in July 2022, when it defined that patients can plant Cannabis in their homes, provided they have a prescription from a doctor for the use of Cannabis.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
National Pharmacovigilance System should be regulated until 2023
During the month of August, ANVISA started the process of Regulatory Impact Analysis on regulating the Brazilian Pharmacovigilance System (“SINAF”). The subject of pharmacovigilance is already under discussion by the Agency; however, there is not yet a central normative act that provides for its procedures and criteria according to which companies must act.
The SINAF acts directly in the management of health risks, aiming at the appropriate use of medicines, to guarantee the safety of patients and the best quality of products. Through the normative act, the result of RIA, pharmaceutical companies will have greater legal certainty in the manufacture and marketing of medicines. The Working Group, composed of members of the Technical Chamber of Pharmacovigilance and representatives of the Health Regulatory Agency, should conclude the analysis by January 2023.
ANS – BRAZILIAN SUPPLEMENTAL HEALTHCARE AGENCY
(ANS, ANVISA and MAPA) Public entities participate in the Public Selection on Artificial Intelligence
On August 02, 2022, a Public Call was launched to support projects of Artificial Intelligence-based solutions (“AI”). This is an initiative from the Ministry of Science, Technology and Innovations (“MCTI”) and aims to merge new technological measures through ANS, ANVISA and the Ministry of Agriculture, Livestock and Food Supply (“MAPA”).
Within the scope of ANS, AI-based initiatives should address the following topics:
- Analyst of digital complaints made by customers of health operators;
- Assistant for changes in registration data for regulated entities;
- Intelligence in qualitative analysis of contributions from society;
- Artificial Intelligence in reimbursement to the Brazilian Unified Health System (“SUS”).
Within ANVISA, the topics are:
- Assessment of authorizations for company operations;
- Assistance and provision of information for the population;
- Monitoring compliance of companies by means of predictive model of health risk;
- Improvement of monitoring processes after marketing of products subject to the health regulatory agency.
And finally, within the scope of MAPA, the topics are:
- Analysis of data and documents for certification of fishermen;
- Assistance in the inspection of aero-agricultural activities;
- Intelligent research assistant on the Brazilian Agriculture Observatory website;
- Identification of technological and market trends for Agro 4.0.
Startups that wish to participate in the selection may send their proposals until September 12, 2022. The amount for each proposal will be compatible with the complexity of the project presented and the complete information can be accessed in the official publication of the Brazilian Funding Authority for Studies and Projects (“FINEP”).
ANS – BRAZILIAN SUPPLEMENTAL HEALTHCARE AGENCY
Coverage for home physiotherapy is a matter of discussion in court
In a preliminary decision, the judges of the 32nd civil court of São Paulo determined that the health insurance plan must cover home physiotherapy expenses after surgery.
The rehabilitation treatment of the patient, after orthopedic surgery, was a duly prescribed medical recommendation. The health operator denied such coverage arguing that such therapy is not covered by the contracted health plan.
The risk of irreparable damage motivated the judges’ decision because of an absence of proper treatment for claimant’s recovery.
ANS – BRAZILIAN SUPPLEMENTAL HEALTHCARE AGENCY
Sex reassignment surgery should be covered by the health plan
The Court of Justice in Minas Gerais decided that sex reassignment surgery should be covered by the health operator.
According to the judges, the steps for the final sex reassignment surgery procedure are provided for in ANS’s list of health procedures and events, such as, for example, total amputation. Therefore, even if the list is considered to be exhaustive, the procedure should be covered by the health plan.
MS – BRAZILIAN MINISTRY OF HEALTH
Open Health is discussed by Working Group
On August 11, 2022, the Ministry of Health’s Working Group released its final report on the improvement of the supplemental health sector through the sharing of user data and health services providers.
The so-called “Open Health” aims to optimize the service of health operators in Brazil, with two fundamental measures: the Open Data, which represents the transparency of data from health plan beneficiaries, and the sharing of registration and transactional information, which should establish the parameters and limits of access to personal information.
The main purpose of the measures provided for in the report is the improvement of consumers’ experience in these transactions and greater agility in access to information.
MAPA – MINISTRY OF AGRICULTURE, LIVESTOCK AND FOOD SUPPLY
Data panel promotes greater transparency of Brazilian agribusiness
The tool called ”Observatório da Agropecuária Brasileira” (Observatory of Brazilian Agriculture and Livestock) will allow greater transparency in the treatment of import and export data from agribusiness. The Ministry of Agriculture, Livestock and Food Supply (“MAPA”) will update monthly this information..
Due to the exponential growth of agribusiness, which already represents BRL 1.22 trillion to the country’s economy, the observatory will enable the analysis of information about the trade of fertilizers and agricultural products, family agriculture, land issues, and other relevant topics for the sector.[/vc_column_text][vc_empty_space height=”40px”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]LEGISLATIONS
Law of the wage floor for nurses is published and the STF must analyze its constitutionality
On August 04, 2022, the Federal Law No. 14,434/2022 was approved and published, establishing the wage floor BRL 4,750.00 for nurses, BRL 3,325.00 for nursing technicians and BRL 2,375.00 for assistant nurses and midwives. Such wage floors apply to professionals employed under the Brazilian Consolidated Labor Laws (CLT).
The law came into force on the date of its publication, and the Federal Government, states, Federal District and cities will have to adjust the remuneration of these positions until the end of the 2022 financial year. However, four days after the publication of the law, the Direct Claim on Grounds of Unconstitutionality (“ADI”) No. 7222 was brought to contest its constitutionality. According to the requesting entity, the Bill (I) affects the financial planning of public bodies and private companies; (ii) it could not have been proposed by congress members, considering that the Chief of the Executive branch has private competence to propose increases in salaries of public servants.
The topic has not yet been analyzed by the STF on the merits, but entities in the sector have already expressed that the law threatens the continuity of essential treatments.
National Congress approves Federal Law on the list of procedures and events of ANS
On August 29, 2022, Bill 2,033/2022 (“PL”) was approved, which provides for changes in the list of health procedures and events governed by Law No. 9,656/1998.
The PL determines that the list of procedures is only a basic reference for health operators and should not be considered as exhaustive and should be updated by ANS at each incorporation. In case of coverage of procedures not provided for in the list, coverage should be authorized upon proof of treatment or procedure effectiveness and/or if recommendations are made by relevant authorities.
In a note, the ANS complained about the PL, since the analysis and technical examination of changes in a compulsory procedure is the Agency’s responsibility. For the ANS, the proposal will generate uncertainties related to the economic impacts caused by the carrying out of procedures not provided for in the list.
The proposal is a response from the National Congress to the STJ, which determined that the list is exhaustive. The President of the Republic will have 15 days to approve the project, with or without vetoes.
Bills
Bill that establishes the wage floor for Physical and Occupational Therapists is approved by the Committee on Economic Affairs
On August 30, 2022, Bill No. 1,731/2021, which is ongoing at the Federal Senate, was approved by the Brazilian Committee on Economic Affairs (“CAE”). The Bill establishes a wage floor of BRL 4,800.00 for physical and occupational therapists.
The main justification for the proposal is to guarantee the worker a wage floor proportional to the complexity of the service provided, since these professionals play a fundamental role in the recovery of patients.
The CAE believes that, like the Federal Law of the wage floor for nurses, this Bill may also be judicialized. However, it is necessary to prioritize the recognition of professionals and their constitutional right to a wage floor equivalent to their work.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Rule extends the use of food additives
On August 17, 2022, ANVISA published RDC 740/2022 to authorize the use of food additives and technology adjuncts in various food categories. The rule came into force on September 01, 2022.
As soon as the rule takes effect, the food sector will be able to use the food additives described in the resolution in the production of fermented alcoholic beverages, sugars, oils, and fats. In addition, new authorized additives have been added.
This provision will offer greater freedom and variety of choice by the manufacturer and may even impact the final price of the food.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Use of Carbendazim in agrochemical products is banned in Brazil
On August 08, 2022, Anvisa published RDC 739/2022 to determine the prohibition of the active ingredient Carbendazim in agrochemical products in the country. The rule came after the conclusion of Public Consultation No. 1,099/2022.
Carbendazim is a kind of agrochemical that fights fungi in plantations and is recurrently used by Brazilian farmers. The discussion about the ingredient began with Public Civil Action 0051862-73.2013.4.01.3400, filed to investigate possible toxicity capable of causing illness and harm to human health. After the Public Consultation and in view of the risks presented, ANVISA decided to ban the active ingredient.
The total ban on import, production, marketing and use of Carbendazim will occur gradually, considering the particularities of each activity.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Acceptance of health surveillance analysis by a Foreign Regulatory Authority should follow objective guidelines
On August 17, 2022, RDC 741/2022 was published, which provides for the general criteria for acceptance of analysis by an Equivalent Foreign Regulatory Authority (“AREE”) in the process of health surveillance with ANVISA.
The resolution defines the new “Optimized Analysis Procedure” to evaluate the analysis of AREE in the authorization, registration, qualification, accreditation, certification, and inspection, among other processes of health surveillance involving foreign companies wishing to start operations in Brazil.
This procedure will enable greater speed in the certification of foreign companies starting operations in the country, eliminating the need for further analysis in verification steps that have already been carried out.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Bioavailability and pharmacokinetic studies must follow specific regulatory criteria
The criteria for conducting bioavailability (“BD”), bioequivalence (“BE”) and pharmacokinetic studies are defined in RDC 742/2022, with the purpose of ensuring the quality, safety and effectiveness of drugs and biological products.
Such studies evaluate the results of drugs or biological products considering their purpose, to measure the effectiveness and safety of the product. Thus, the resolution determined objective criteria for the analysis, such as the presentation of a study dossier, limitations on the drug under study, safety parameters during the clinical stage of testing, and the form of administration of the drug.
Pharmaceutical companies should adapt their procedures to drug studies by July 2023.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Project establishes aid and support to Family Agriculture
On August 17, 2022, Ordinance 287/2022 was published, establishing the Hubtech Project for Family Agriculture. This MAPA initiative fosters the development of institutional arrangements (virtual Hubs) to provide relevant agricultural information and content to extensionists, farmers and other related persons.
The Virtual Hubs will promote actions of curation, organization, and systematization of information/content, in addition to support of information in the virtual space.
The proposal is based on the Ater Digital Program, which aims to improve the quality of life of farmers and rural families. Thus, the Hubtech Project will have an important role in the technical development of family farmers.
[/vc_column_text][vc_empty_space height=”40px”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]PUBLIC CONSULTATIONS AND HEARINGS
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Analysis of the impacts of Agrochemical Active Ingredients is subject to public consultation
ANVISA opened a 60-day Public Consultation criticism and suggestions regarding the IN 103/2021, which updated the Monographs of Active Ingredients of Pesticides, Sanitizing Disinfectants and Wood Preservatives.
The rule is a consequence of RDC 571/2021 and comprises over 500 active ingredients. The resolution provides for the regulatory process for approval of these ingredients, and defines approval parameters for monographs, such as the evaluation of authorization requests, documents, or updates of the scientific knowledge of a given active ingredient.
All active ingredients are approved through a technical opinion by ANVISA and this Public Consultation will be useful for the companies in the sector to submit their considerations on the quantity and quality of monographs approved as well as suggestions for improvement to contribute with their performance in the market.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
ANVISA receives proposals on the temporary sale of 70% ethyl alcohol to combat Monkeypox outbreak
The Public Consultation analyzes the possibility of a proposal for temporary authorization to freely sell and donate ethyl alcohol of 70% concentration, due to the public health emergency caused by the outbreak of Monkeypox. Contributions may be submitted by September 13, 2022.
Currently, the trade of alcohol with a concentration above 54% is only allowed for hospital use, due to its high concentration. However, due to the advance of the monkeypox outbreak, ANVISA is evaluating the possible temporary authorization for such sale to be carried out without restrictions.
ANS – BRAZILIAN SUPPLEMENTAL HEALTHCARE AGENCY
Proposal for new mandatory coverage in the list of procedures is examined
During the month of August 2022, Public consultation No. 100 was introduced and received more than a thousand contributions on the proposed Normative Resolution that includes mandatory coverage in the List of Health procedures and Events.
The proposal defines that Hepatic Transplant (liver transplant) procedures and Oral Antineoplastic Therapy medications for cancer treatment are compulsory coverages carried out by health operators.
The ANS issued a favorable preliminary recommendation for both incorporations, and the Resolution should be published in the coming weeks.
MAPA – MINISTRY OF AGRICULTURE, LIVESTOCK AND FOOD SUPPLY
The National Irrigated Agriculture Program receives proposals for improvements
The Irriga+Brasil Program is the subject of a 30-day Public Consultation, with the purpose of enabling widespread dissemination of the program proposal through the contribution of agencies, representative bodies, individuals and companies interested in the topic. Contributions may be submitted by September 22, 2022.
The Irriga+Brazil Program is a MAPA initiative, and its main guideline is to implement the use of irrigation on a sustainable basis to produce food, fiber and bioenergy. The guidelines and program planning are available on the official website.
MAPA – MINISTRY OF AGRICULTURE, LIVESTOCK AND FOOD SUPPLY
Public Consultation receives proposals on the Regulation for Inspection of Plant-based Products
The Public Consultation for discussion and analysis of the proposed Regulation for Inspection of Plant-based Products has been extended for 60 days and will receive proposals by October 22, 2022.
The proposed Regulation establishes quality control criteria, good practices, sampling procedures, accreditation, registration, and certification procedures, besides constituting the Brazilian System of Inspection of Plant-based Products.
The regulation will enable greater food safety in consumption of plant-based products as well as establish a more predictability of technical criteria for companies in the sector.[/vc_column_text][vc_empty_space height=”40px”][/vc_column][/vc_row]
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