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
STF establishes new rules regarding non-standard drugs
In April 2023, the Brazilian Federal Supreme Court (“STF”) suspended ongoing trials involving the supply of medicines registered with Anvisa, but not included in the standard list of the Brazilian Unified Health System (“SUS”).
However, this suspension does not apply to ongoing proceedings in trial and appellate courts.
This decision established temporary parameters regarding the competence of the Federal Government, the States, and Municipalities in regard to:
- judicial demands involving standard medicines or treatments; and
- legal demands relating to non-standard drugs within the scope of SUS.
Notwithstanding the above, the national suspension was maintained for special and extraordinary appeals regarding the competence of the Federal Government and the Federal Courts in proceedings that address the supply of medicines registered with Anvisa, but that are not included in the standard list of SUS.
Anvisa changes inspection procedures at ports and airports
On April 28, 2023, Anvisa established that inspection procedures at ports and airports must be carried out through the Electronic Information System (“SEI”).
The sanitary terms of inspection and notice resulting from monitoring procedures must be submitted through the SEI, along with documents proving compliance with the sanitary notices.
The SEI system is available here and companies can already register.
ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY
Labor Courts deny the extension of healthcare coverage to employees outside of the COVID-19 risk group
On December 12, 2022, the 17th Panel of the Regional Labor Court of the 2nd Region decided that employees who do not fall under the Covid-19 “risk group” are not entitled to the extension of healthcare coverage for the same period of time that is granted to employees included in such “risk group”.
The Court understood that beneficiaries included in the risk group are more likely to develop complications from the disease that may lead to death, which justifies differentiated treatment regarding the extension under discussion.
Read the decision in full here.
STJ rules in favor of considering the grandson of an insurance policyholder as dependent
On April 25, 2023, the 3rd Panel of the Superior Court of Justice (“STJ”) unanimously decided that the grandson of a health plan policyholder should be considered a dependent within the plan, and classified the grandson as a
As such, the judge accepted part of the claim to include the grandson in the insurance policy as a dependent, as well as authorized the collection of monthly fees by the healthcare operator after the 30th day of the child’s life.
Read the decision in full here.
MS – BRAZILIAN MINISTRY OF HEALTH
Cannabis: judicial decision authorizes dental-care patient to plant cannabis at home
The STJ decided to authorize a dental-care patient to cultivate Cannabis sativa for their own use throughout a dental treatment.
The patient claimed to have tried other medicines that were ultimately ineffective.
The case had been processed in first instance by the Court of Justice of Santa Catarina (“TJSC”). However, due to the suspension of the proceeding, the claimant was forced to wait for more than four months for a court decision. As a result, the matter was forwarded to the STJ, which granted safe conduct – that is, granted the claim – to the patient, on the grounds that there is already a consolidated opinion regarding this matter.
Ministry of Health publishes notice reinstating the Mais Médicos program
On April 18, 2023, a new notice for Programa Mais Médicos (Mais Médicos Program) was published, which offers physicians more than 6,000 job positions across more than 2,000 cities across Brazil.
The cities listed as eligible for the program by the Ministry of Health must submit their application within the deadline through the Basic Care Information and Management System (e-Gestor AB).
Each municipal government will be responsible for entering into or renewing the Participation and Commitment Agreement according to the rules established by the Ministry of Health.
The Department of Primary Health Care will publish, on its official website, the list of cities whose participation and respective job positions were confirmed in accordance with the Participation and Commitment Agreements executed.
CCJ approves bill that establishes requirements for the purchase of equipment by SUS
On April 26, 2023, the Committee on Constitution and Justice and Citizenship (“CCJ”) approved Bill No. 2,641/2019, which provides for the minimum requirements regarding the purchase of equipment used in diagnostic or therapeutic procedures within the scope of SUS.
The bill amended the New Bidding Law in order to ensure that the procedure to contract equipment is in compliance with the following requirements:
(i) demonstration of adequate budget to carry out maintenance and operation of the equipment;
(ii) schedule for the training or hiring of qualified professionals to operate the equipment;
(iii) schedule for construction work or adaptation of the locations where the equipment will be operated, prior to its delivery.
According to the justification given, the goal is to improve the objectivity and efficiency of equipment purchase procedures carried out by SUS, through the mandatory analyses regarding the adequate use of such equipment in the course of its working life.
The text will move forward for further analysis by the CCJ.
Ban on new medicine courses in Brazil lifted
On April 06, 2023, the Ministry of Education (“MEC”) suspended Ordinance No. 328/2018, which banned the creation of new medical courses in Brazil in order to halt the proliferation of unqualified medical schools.
Subsequently to the lifting of this ban, the opening of new enrollment slots must be carried out through public calls initiated by the MEC, in accordance with the 2023 Mais Médicos Law. In this regard, on April 06, 2023, the MEC published Ordinance No. 650/2023 , which, among other measures:
- repealed Ordinance No. 328/2018;
- established the policy to initiate public calls aimed at authorizing the provision of undergraduate medical courses in private institutions of higher education; and
- provided for the re-opening of requests for the increase of enrollment slots within the federal system of higher education.
For more information on the topic, read our Client Alert published in April.
MAPA – MINISTRY OF AGRICULTURE, LIVESTOCK AND FOOD SUPPLY
New plant protection products registered by MAPA
On April 18, 2023, Ordinance No. 769/2023 was published, which introduced new reference specifications (“ER”) for the registration of phytosanitary products (plant protection) approved for use in organic agriculture.
The main innovation introduced by the Ordinance is ER 56, whose active ingredient can significantly reduce the population of woodworms (weevils) in stored products. Before the Ordinance, no product registered in Brazil contained biological agents capable of combating the storage pests that ER 56 does.
It is also worth highlighting that nearly 300 phytosanitary products have already been approved for use in organic agriculture, which shows that the sector is increasingly focused on ensuring agriculture sustainability.
Superintendence of Agriculture of São Paulo carries out drone operation training to modernize inspection procedures
In April, 2023, the Superintendence of Agriculture of São Paulo carried out drone operation training with MAPA employees.
The goal is to use the drones to modernize and increase efficiency in audits, inspections and intelligence activities.
The training schedule is expected to be complete by September, 2023, so that MAPA employees can begin using the new equipment.
COFEN – FEDERAL NURSING COUNCIL
Bill allocates BRL 7.3 billion to secure nursing wage floor
On April 18, 2023, the President of Brazil proposed National Congress Bill No. 5 regarding the allocation of special credit to the Federal Social Security Budget in the amount of BRL 7.3 billion to the Ministry of Health.
The bill was highly anticipated by nursing professionals, given that Constitutional Amendment No. 124/2022 and Law No. 14,434/2022, which provided for the national nursing wage floor, was not viable do the budgetary restraints.
Find out more in our Client Alert.
MS – BRAZILIAN MINISTRY OF HEALTH
New federal law secures replacement of breast implants for cancer patients in the event of complications
On April 03, 2023, Law No. 14,538/2023 was published, which, among other measures, secures the replacement of breast implants used in breast reconstruction or contralateral breast symmetrization, in the event of complications or adverse effects resulting from the implant.
In addition to the implant replacement, the new Law ensures specialized psychological and multidisciplinary follow-up treatment to patients that undergo total or partial mutilation of the breast as a result of cancer treatment procedures.
The new rule will encompass both the private sector and SUS. In the latter case, the implant replacement must be carried out within 30 days of the appointment with the physician that recommended the procedure under discussion.
Although published in April, Law No. 14,538/2023 will only enter into force on July 03, 2023.
MAPA – MINISTRY OF AGRICULTURE, LIVESTOCK AND FOOD SUPPLY
Agricultural Development Plan for the Amazon brought forward
On April 05, 2023, Ordinance No. 575/2023, which created the “Agricultural Development Plan for the Amazon – Plano Amazônia + Sustentável”, within the scope of MAPA.
The Plan seeks to foster public policies in agriculture and land planning. Additionally, the Plan aims to add value to the agricultural chains as a way of ensuring the generation of income and food supply for the region and, consequently, discouraging illegal deforestation of the Amazon.
The Plan will encompass all states of the Legal Amazon, prioritizing territories at the macro-regional, sub-regional and local scales.
In parallel, on April 05, 2023, Ordinance No. 576/2023 was also published, which introduced the management model of the “Agricultural Development Plan for the Amazon – Plano Amazônia + Sustentável”.
The model divided the management of the Plan as follows:
I – Management Unit of the Amazônia + Sustentável Plan: the central unit in charge of the Plan, responsible for coordinating programs and projects;
II – Central Committee for the Coordination of the Amazônia + Sustentável Plan: deliberative body at the national level, which aims to establish the communication between specific entities of MAPA; and
III – State Committees for the Coordination of the Amazônia + Sustentável Plan: deliberative bodies at the state level that aim to execute and monitor the Plan in each participating state.
Second phase of AgroNordeste plan released
On April 06, 2023, Ordinance No. 577/2023 was published, which introduced the second phase of the action plan for the Northeast of Brazil (“AgroNordeste”), named “Nordeste + Sustentável”.
The “Nordeste + Sustentável” plan was developed by MAPA to carry on the Agricultural Development Plan for the Amazon, in order to stimulate the sustainable development of the agricultural sector in the Northeast region of Brazil and in the North of Espírito Santo and Minas Gerais.
CFM – BRAZILIAN FEDERAL COUNCIL OF MEDICINE
Physicians prohibited from prescribing anabolic steroids for aesthetic purposes, sports performance, and muscle gain
On April 11, 2023, CFM Resolution No. 2,333/2023 was published, which adopted ethical rules in accordance with scientific studies that contraindicate the prescription and use of anabolic-androgenic steroids for aesthetic purposes, muscle gain and enhancement of sports performance, due to potential health risks.
As a result, physicians are now prohibited from prescribing anabolic steroids for the purposes mentioned above.
The justification of the Resolution addresses the increasing number of cases involving complications due to the misuse of hormones. Regardless of this prohibition, the new rule expressly authorizes the use of these steroids in the treatment of specific medical deficiencies that have been proven to improve through hormone replacement therapy.
PUBLIC CONSULATIONS AND HEARINGS
SF – FEDERAL SENATE
Medicinal use of cannabis addressed in public hearing held by the Federal Senate
On April 19, 2023, the Federal Senate held a public hearing on the medicinal use of cannabis in the treatment of autism, chronic pain and specific diseases such as depression and epilepsy.
Senators and members of civil society joined the hearing, which involved the analysis of suggestions regarding bills currently in process in the National Congress. Currently, Bills No. 4,776/2019 and No. 89/2023 are pending approval. These bills establish the regulation of the production, sale and supply of cannabis-based medicines and products through SUS.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Public Consultation addresses rule on the registration of new foods and ingredients
On April 26, 2023, a Public Consultation was initiated to analyze the proposed update to Resolution No. 16/1999, which provides for the regulation on procedures regarding the registration of foods and new ingredients.
As such, the goal of the consultation is to improve the regulation on the matter in order to clarify the classification and definition procedures for such products, as well as to establish more objective criteria in the evaluation of foods.
Contributions can be submitted through this link, by July 31, 2023.
MAPA – MINISTRY OF AGRICULTURE, LIVESTOCK AND FOOD SUPPLY
Regulations on dairy products analyzed through Public Consultation
In April, the MAPA initiated two Public Consultations to obtain contributions regarding proposals for the technical regulation on the identification and quality of dairy beverages and dairy compounds.
The proposals establish the criteria for the processing and handling of ingredients, as well as the criteria for production and registration of such products.
Related Areas
Share
Newsletters
