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 reading!
Demarest’s Life Sciences Team
ANVISA – Brazilian National Health Regulatory Agency
Anvisa announces the number of bio-based products approved in 2022 for use in agriculture
ANVISA has recently announced it has carried out analyses of 157 applications for approval of bio-based products aimed at pest and disease control in agriculture in 2022, which represents a 70% increase from 2021.
Such consistent development demonstrates the importance of the sector for the Brazilian Federal Government, which prioritizes the analyses of applications mentioned above within approximately four months.
The Ministry of Agriculture, Livestock and Food Supply (“MAPA”) joined the discussion by restating its commitment to environmentally responsible production, seeking to align the progress of field production with the protection of the environment.
The use of bio-based products in pest and disease control represents lower risks to human health and to the environment, especially if compared to traditional pesticides.
The matter is still pending specific legislation, but is expected to be regulated in 2023.
ANS – Brazilian Supplementary Healthcare Agency
ANS establishes Regulatory Agenda for 2023-2025
On January 19, 2023, ANS established the new 2023-2025 Regulatory Agenda, divided into:
- regulatory matters;
- schedule for Regulatory Result Evaluation (ARR); and
- preliminary studies.
Among the topics addressed in the document, we highlight:
- the improvement of the relationship between operators and beneficiaries;
- the integration between the supplementary private health sector and the Brazilian Unified Health System (SUS); and
- the possibility of beneficiaries contracting or switching health care plans.
The new schedule aims to ensure the sustainability of the sector across the next few years and is the result of a joint effort between ANS and society through contributions to a Public Call held in 2022.
ANS – Brazilian Supplementary Healthcare Agency
IRRF must be levied against payments carried out by healthcare operators to affiliated providers
On January 04, 2023, Answer to Inquiry No. 3, of the Federal Revenue of Brazil, was published, which settled a dispute regarding the levying of the withholding income tax (“IRRF”) against payments carried out by health care operators to physicians, dentists and other professionals that belong to the accredited network of health care plans, although the relationship between the parties is limited to the accreditation within such a plan.
According to the Federal Revenue, the decision is binding and must be taken into consideration in any disputes that are within the scope mentioned above.
MS – Brazilian Ministry of Health
Ministry of Health repeals regulation that contradicts SUS guidelines
In January 2023, the Ministry of Health repealed several ordinances approved by the former presidential government. According to the Ministry of Health, such ordinances went against SUS guidelines and failed to involve the competent government authorities in the regulation process.
One of these ordinances required users of the Brazilian Popular Pharmacy Program (Farmácia Popular) to submit an electronic prescription to receive their medication, for alleged security reasons. The Ministry of Health decided that, in addition to creating obstacles to the population’s access to medication, the ordinance lacked transparency, given that its drafting process had not been carried out in alignment with state and municipal governments.
Also, the ordinances that were repealed represented a downgrade regarding reproductive and sexual health rights, due to maneuvers deemed as obstetric violence, including changes to the prenatal booklet. The Ministry of Health reinstated the “Stork Network” program (“Rede Cegonha”), which aimed to ensure safe and high-quality care across all stages of pregnancy.
Subsequent to the repeal, the Ministry of Health aims to expand communication with competent authorities in order to ensure increased legal certainty regarding the regulations that are currently in force.
Below is the list of ordinances that were repealed:
- GM/MS Ordinance No. 4,809/2022, which “implements the Permanent Forum for Articulation with Civil Society”.
- GM/MS Ordinance No. 1,079/2022, which “establishes national programs aimed at the prevention and early diagnose of cancer, within the scope of Brazil’s National Cancer Prevention and Control Policy”.
- GM/MS Ordinance No. 2,561/2020, which “provides for the Procedure to Justify and Authorize Pregnancy Termination in cases provided for by law, within the scope of the Brazilian Unified Healthy System – SUS”.
- GM/MS Ordinance No. 3,473/2022, which “amends GM/MS Consolidation Ordinance No. 5, of September 28, 2017, to provide for the Technical Chamber for Assistance in Immunization Procedures, and include other provisions”.
- GM/MS Ordinance No. 715/2022, which “amends GM/MS Consolidation Ordinance No. 3, of September 28, 2017, to provide for the Network for Maternity and Childhood Care (Rami)”.
- GM/MS Ordinance No. 2,228/2022, which “amends GM/MS Consolidation Ordinance No. 3, of September 28, 2017, and GM/MS Consolidation Ordinance No. 6, of September 28, 2017, to provide for the accreditation and financing of the Network for Maternity and Childhood Care (Rami)”.
- The head provision and sole paragraph of art. 21-A of Annex LXXVII of GM/MS Consolidation Ordinance No. 5/2017, which “consolidates rules regarding health practices and services within the scope of the Brazilian Unified Health System”.
MS – Brazilian Ministry of Health
A Secretariat of Digital Health is created, highlighting technological innovation targets
In January 2023, the Ministry of Health announced the creation of the Secretariat of Digital Health, headed by professor and researcher Ana Estela Haddad.
The entity was created due to increasing demand regarding matters of connectivity, telehealth, and data sharing within the scope of SUS.
After the consolidation of the regulation on such topics, the main target of the Secretariat will be to expand telehealth services in Brazil, in addition to structuring a National Health Database (RNDS).
MS – Brazilian Ministry of Health
São Paulo Government suspends ordinance that raises drug prices
In Brazil, the price of medicines rises in line with the increase of the State Tax on Circulation of Goods and Services (ICMS) and with the reference index of the Weighted-Average Price for the End Consumer (PMPF). In 2023, the publication of SRE Ordinance No. 116/2022 substantially increased the price of such products following the definition of a tax calculation base.
The impacts resulting from the rule led pharmaceutical laboratories to request the suspension of the price increase to the State Department of Tax and Finance, highlighting the risk of a shortage of essential medication due to the increased costs.
In light of the negative repercussion of the rule, as well as pressure from companies of the sector, the Government of the State of São Paulo published, on February 01, 2023, SRE Ordinance No. 04/2023, which postponed the entry into force of SRE Ordinance No. 116/2022 and, consequently, the medication price increase.
The Government expects the pharmaceutical industry to submit valid arguments and evidence to justify the need to reassess the tax calculation base and, the definition of medication prices.
MS – Brazilian Ministry of Health
New developments regarding the nursing wage floor
On January 27, 2023, the Working Group of the Ministry of Health held a meeting to discuss and assess the impacts of Law No. 14,434/2022, which implemented the nursing wage floor.
The law has remained suspended since September 2022 due to the preliminary decision of the Federal Supreme Court (STF) through ADI No. 7,222. The Ministry of Health was required to submit information within the scope of SUS regarding the viability of the nursing wage floor in the public health system.
The Working Group of the Ministry of Health was created to assess the developments of the topic, and consists of the National Nursing Forum, the National Council of Secretaries of Health and National Council of Municipal Secretariats of Health.
In addition, the current Minister of Health has already stated her commitment to resolving the matter, as reported by the Ministry of Health in this link.
MS – Brazilian Ministry of Health
Controversy regarding new medical schools highlighted in the presidential government transition
Only three days after the inauguration of the new presidential government, the new Ministry of Education has implemented a significant change: the repeal of Ordinance No. 1,061, published on December 31, 2022, which had authorized the creation of new medical schools.
The repealed ordinance established rules that were similar to the Mais Médicos program, in addition to defining strategies aimed at the inclusion of students in the local health system, the qualification of medical residency programs and at offering scholarships.
In parallel, as reported by the Ministry of Health, the new Minister of Health has already stated that restructuring the Mais Médicos program is a priority of the new presidential government. As such, the next months are likely to see the Ministries concentrate efforts on establishing a strategy to create new medical schools and reinstate the Mais Médicos program.
MAPA – Ministério da Agricultura, Pecuária e Abastecimento
MAPA publishes checklist to improve quality control of plant-derived products
MAPA has published a list of quality evaluation criteria to support recent initiatives aimed at improving the quality control procedures of Brazilian companies regarding plant-derived products sold in Brazil and internationally.
The list establishes good measures and practices according to domestic and international private certification frameworks that also comply with the requirements of importing countries.
In addition, the checklist will serve as a reference for inspection procedures. During an inspection carried out in São Paulo, MAPA identified deficiencies in the use of computer-based systems for organic food traceability through QRCodes, which failed to identify food producers. Such defects demonstrate that the inspection process still requires improvements, especially in regard to the training and qualification of teams that disclose product data.
São Paulo approves the first law that authorizes SUS to provide cannabis-derived medicine in the state
In January 2023, the governor of São Paulo 2022 approved State Law No. 17,618/2023, which established a state policy providing for the dispensing of cannabidiol plant-based medicines, free of charge, in public and private health facilities associated with the Brazilian Unified Health System (“SUS”) in the State of São Paulo..
As a result, São Paulo became the first state in Brazil to provide cannabis-derived drugs through SUS. For more information on the topic, read our Client Alert.
MS – Brazilian Ministry of Health
Federal District sanctions law that authorizes telehealth services in the public and private health system
Days after the Telehealth Law was published, the governor of the Federal District (“DF”) sanctioned State Law No. 7,215/2023, which authorizes the carrying out of telehealth services in the public and private health system in Brazil.
In addition to provisions similar to the Telehealth Law, the law also provides for:
- requirement for the qualification of the physician that will provide telehealth services in bioethics, digital responsibility, and digital safety; and
- training on digital health media to qualify the doctor that will provide telehealth services.
It is worth highlighting that such provisions are a complement to the competent federal law.
Additionally, the initiative of the DF is expected to be followed by local regulations across other states of Brazil. In parallel, the Federal Government is also prioritizing telehealth as part of the new development targets of SUS.
MAPA – Ministry of Agriculture, Livestock and Food Supply
New nomenclature criteria for animal products approved
On January 30, 2023, Ordinance No. 744/2022 was published, which approved the new nomenclature standards for the sale of edible organic meat products. The ordinance will enter into force on March 01, 2023.
The purpose is to standardize criteria to ensure that the nomenclature used for sale will be true to the characteristics of the product bought by the end consumer. The ordinance provides for the following meat products: poultry, ostrich, beef, goats and pork.
Establishments can include the popular and local nomenclatures of the animal products, provided that the packaging contains the official nomenclature, observing the corresponding bone and muscular base reference of each meat product.
PUBLIC CONSULTATIONS AND HEARINGS:
ANVISA – Brazilian National Health Regulatory Agency
Clinical data analysis subject to Public Consultation
On January 11, 2023, Public Hearing No. 11 was held to obtain contributions of the Regulatory Procedure to review RDC No. 302/2005, which provides for the Technical Regulation regarding the operation of Clinical Laboratories.
ANVISA proposed the new wording of the RDC, aiming to update the quality and control management requirements regarding clinical data analysis and “rapid tests”, in order to ensure the safety of the user and stimulate progress within the diagnosis sector.
MAPA – Ministry of Agricultura, Livestock and Food Supply
Public Consultation analyzes simplification of agrochemicals registration
On January 02, 2022, a Public Consultations was initiated to analyze a proposed Joint Ordinance between MAPA, ANVISA and the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA), which provides for the assignment of pending applications for the registration of agrochemicals.
The proposal aims to improve the procedure to evaluate products that will be produced with the same active ingredients, establishing a limit of 20 agrochemicals registration procedures with the same active ingredients that can be assigned.
MAPA – Ministry of Agricultura, Livestock and Food Supply
Public Consultation analyzes traceability of beef and bison meat production
On January 02, 2022, a Public Consultation was opened to gather contributions on the proposed regulation for control procedures regarding the traceability of the beef and bison meat production chain in Brazil.
The proposal is aimed at standardizing the control of the production and ensure a high-quality product to the consumer. Interested parties can submit contributions by February 14, 2023.
The proposal aims to improve the procedure to evaluate products that will be produced with the same active ingredients, establishing a limit of 20 agrochemicals registration procedures with the same active ingredients that can be assigned.
In addition, the proposal provides for a potential simplified analysis of products that have the same qualitative and quantitative composition, as well as the same formula of another product that has already been registered, evaluated, or submitted for evaluation with a full study.
Contributions can be submitted by March 02, 2023.
Related Areas
Share
Newsletters
