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
Cannabis: STJ decision on medicine supply and IFA production in Brazil mark the month of May
In May 2023, the Superior Court of Justice (“STJ”) and Anvisa addressed discussions regarding the supply of cannabidiol for medicinal purposes.
On May 16, 2023, the 2nd Panel of the STJ unanimously decided that the Federal Government and the state of Pernambuco must provide Cannabis Products for the treatment of chronic illness through the Brazilian Unified Health System (“SUS”). The decision regarding Resp No 2006118/PE has yet to be published in full.
In parallel, Anvisa unprecedentedly authorized Brazil to produce the active pharmaceutical input (“IFA”) of cannabidiol. Previously, Anvisa had only authorized Cannabis Products in final form. Consequently, the production of cannabidiol IFA in Brazil will increase autonomy for producers, thus reducing the price of the final product.
MS – BRAZILIAN MINISTRY OF HEALTH
New developments regarding nursing wage floor in the private sector
Since the publication of Law No. 14,581/2023, which included the national nursing wage floor in the government budget, there have been new developments regarding its implementation in the public and private sectors.
Within the scope of ADI 7222, which analyzes the constitutionality of the nursing wage floor law (Law No. 14.434/2022), the Brazilian Federal Supreme Court partially repealed the injunction, which had been in force since September 2022, in order to (i) re-establish the validity of the nursing wage floor law within the public sector and (ii) enable the execution of collective agreements within the private sector, as an alternative to prevent mass dismissals.
The ADI trial is currently suspended due to minister Gilmar Mendes’ request for examination and is expected to resume soon.
State of Goiás establishes state policy regarding the supply of cannabis-based medicines through SUS
On February 01, 2023, the state of Goiás published Law No. 21,940/2023, which established a state policy for the free supply of cannabidiol, cannabigerol and tetrahydrocannabidiol-based medicines through SUS.
Although an advance regarding government policies, the measure can also create obstacles due to not providing for the supply of Cannabis Products, which was regulated by Anvisa through RDC No. 327/2019. In this regard, the Goiás policy is in line with the São Paulo policy.
As a result, other Brazilian states are expected to follow suit and institute state policies, especially given the lack of regulations at the federal level.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
Clinical laboratories regulations updated
On May 10, 2023, RDC No. 786/2023 was published, which modernizes and amends the technical and sanitary requirements to the operation of:
- clinical laboratories;
- anatomical pathology laboratories; and
- other establishments that carry out clinical analysis procedures (“EAC”).
According to the new regulation, drugstores and isolated practices are now allowed to collect and carry out clinical analysis procedures, provided that such analysis is entirely carried out after the collection of the sample inside the respective establishment; and that there is no requirement for equipment to read, interpret or visualize the results of the analysis.
Find out more in our client alert on RDC No. 786.
ANVISA – Brazilian National Health Regulatory Agency and MAPA – Ministry Of Agriculture, and Livestock
Joint Ordinance establishes registry procedure for microbiological products
On May 04, 2023, Anvisa, MAPA, and Ibama published Joint Ordinance No. 1/2023, which establishes registry procedures for microbiological products used in pest control or as plant regulators, stimulants, defoliants, or desiccants.
The goal is to enable the registration of new products to be registered, as well as stimulate the use of microbiological technology by the sector. The three federal authorities mentioned above will be in charge of regulating these products, collaborating to analyze the studies and documents submitted.
Find out more in our client alert on Joint Ordinance No. 1.
MS – BRAZILIAN MINISTRY OF HEALTH
Project Mais Médicos para o Brasil regulated
On May 18, 2023, MS/MEC Interministerial Ordinance No. 604 was published, which provides for the Mais Médicos para o Brasil project (PMMB), which was reinstated through Provisional Measure No. 1,165/2023.
The program is aimed at providing advanced training and post-graduate courses to qualify physicians through education and research institutions. The ordinance aims to:
- Reduce the shortage of physicians in priority areas for SUS, in order to reduce inequality among different regions in regard to health services.
- Improve medical training in Brazil and provide more practical experience throughout the education process, in addition to fostering medical students’ knowledge regarding public health in Brazil through expanded opportunities to practice in SUS units.
- Train doctors to practice in accordance with public health policies in Brazil and to improve the structure and operation within SUS.
- Expand the offering of professional specialization in strategic areas for the SUS.
MAPA – MINISTRY OF AGRICULTURE AND LIVESTOCK
Hygienic, sanitary and technological regulation on bee products published
On May 10, 2023, Ordinance No. 795/2023 was published, which established hygienic, sanitary and technological regulations for producers of bee products and derivatives.
This ordinance simplified the process to register production facilities in accordance with the minimum infrastructure and equipment requirements. Another important update defined requirements to the processing of honey, bee pollen, bee wax, propolis, propolis extract, royal jelly and stingless bee honey, which must be taken into consideration by producers to apply for registration with the Federal Inspection Service (SIF).
The ordinance enters into force on June 01, 2023 and producers will have 365 days, calculated from the date of publication, to adjust to the new regulation.
On May 10, 2023, Ordinance No. 798/2023 was published, which established the minimum requirements and procedures for the production and use of animal feed products that include veterinary medicinal products (“medicated feed”).
MAPA seeks to ensure the prudent use of medicines in animal feed products, in order to prevent antimicrobial resistance. The ordinance stresses that any manufacturer of animal feed products must have prior authorization from the MAPA.
The ordinance enters into force on June 01, 2023 and producers will have 180 days, calculated from the date of publication, to adjust to the new regulation.
MAPA ordinance amends normative instructions that regulate alcoholic beverage identification and quality standards
On May 29, 2023, MAPA Ordinance 586 of May 16, 2023 was published, which amends Normative Instruction No. 15 of March 31, 2011; and Normative Instruction No. 29 of September 19, 2012.
The ordinance provides for alcoholic beverage identification and quality standards, establishing requirements to use certain wording on the labels of Brazilian and imported products.
The ordinance will enter into force on July 03, 2023.
MAPA updates list of substances and practices for use in Organic Production Systems
On June 01, 2023, SDA Ordinance No. 811 of May 29, 2023 was published, amending Annexes I, II, III, IV, V and VI of Ordinance No. 52 of March 15, 2021, which established the Technical Regulation for Organic Production Systems and provides the lists of substances and practices for use in organic production systems.
The aim of the standard is to correct and regulate the list, which contains substances and products for use in organic production systems, together with their respective conditions of use.
The ordinance will enter into force on May 02, 2023.
CFM- BRAZILIAN FEDERAL COUNCIL OF MEDICINE
Resolution grants temporary visa for physicians to practice in a different state
On May 03, 2023, CFM Resolution No. 2.331/2023 was published, which provides for the granting of a temporary visa for physicians to practice in a different state, for up to 90 days, and without any employment bond.
In other words, the resolution introduces limits in regard to work schedule and fiscal year (for tax purposes). In this regard, this temporary visa can only be provided for 90 consecutive calendar days within the same year. However, in the case of certain medical specialties, such visa can be granted in fractioned periods.
PUBLIC CONSULTATIONS AND HEARINGS
ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY
Public hearings address bill that revises Healthcare Plan Law
Between May 12 and May 28, 2023, public hearings were held in São Luís and Rio de Janeiro to discuss Bill No. 7419/2006, which provides for a revision of the Health Plans Law (Law No. 9.656/1998), regarding private healthcare insurance plans.
A third meeting is scheduled in Brasilia for the first week of June.
The bill is being processed under the fast-track procedure and provides for the coverage by healthcare plans of expenses relating to the accompanying individual of patients under 18 years of age, including admission to the intensive care unit or similar facilities, provided that there is medical recommendation.
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