Check out our monthly Life Sciences Newsletter, which gathers information about recent legislation, news, significant decisions, public consultations and bills concerning the health and agribusiness sectors in Brazil.
For more information, please contact our lawyers.
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Demarest’s Life Sciences Team
ANVISA – Brazilian National Health Regulatory Agency
Anvisa releases schedule of regulatory proposals for 2023
In March 2023, Anvisa published the Regulatory Projects Monitoring Panel for the 2021-2023 Agenda, which contains the proposed schedule for projects included in its 2023 Regulatory Agenda.
According to the document, projects can now be monitored from the initial study phase until the final version, including the phase of contributions to public consultations.
The purpose of this Monitoring Panel is to ensure greater certainty and security for interested parties within the sector, as well as increase the transparency of Anvisa’s internal proceedings.
ANVISA – Brazilian National Health Regulatory Agency
Public company in Goiás enters into agreement to authorize the production of CBD oil for distribution by the SUS
In March 2023, a state-owned laboratory from Goiás entered into a technology transfer agreement with a U.S. company.
This agreement will enable the production of cannabis products to be distributed by the Brazilian Unified Health System (“SUS”) across the state of Goiás. Initially, the laboratory will produce two types of oil within the “CBD full spectrum” for oral administration, one with 100mg/ml and the other with 200mg/ml.
The agreement represents an innovation milestone for the sector, which is expected to stimulate similar initiatives across other states in Brazil.
ANS – Brazilian Supplementary Healthcare Agency
STJ decides that health care plans must only reimburse medicines after registration with Anvisa
On March 07, 2023, the Superior Court of Justice (“STJ”) issued a decision regarding Special Appeal No. 1,799,666-PR. By 4 votes to 1, the STJ decided that health care plan operators must only reimburse medicines to the insured party after the product is duly registered with Anvisa.
This decision is aligned with the position established by the STJ in 2020, through Matter 990, according to which “health care plan operators are not obliged to provide medicines that have not been registered with Anvisa”.
ANS – Brazilian Supplementary Healthcare Agency
STF decides that law regarding full health care coverage for people with disabilities is unconstitutional
The Brazilian Federal Supreme Court (“STF”), in regard to ADI 7208, decided that health care operators are not obliged to comply with Law No. 11,816/2022 of the state of Mato Grosso , which provided for the offer of special treatment aimed at people with disabilities.
The Direct Action of Unconstitutionality (“ADI”) analyzed the unconstitutionality of Law No. 11,816/2022, which provided for the obligation of health care operators to ensure full coverage of care and provide appropriate treatment for people with disabilities, regardless of any plan coverage restrictions.
The STF decided that Law No. 11,816/2022 disregarded the competence of the Federal Government to legislate on matters of civil law and insurance policy.
MS – Brazilian Ministry of Health
STJ suspends actions relating to the cultivation of medicinal cannabis
On March 14, 2023, the 1st District of the Superior Court of Justice suspended all legal actions relating to the cultivation of cannabis for medical, pharmaceutical and industrial purposes until a precedent is set for the matter by the STJ.
The decision applies to individual and collective cases. According to the decision, the amount of canabidiol that can be produced through home cultivation must be analyzed. As a result, the judge invited entities and authorities that have interest and experience on the matter to submit their contributions.
It is worth highlighting that, in recent months, there has been an increase in legal actions on the matter.
The full decision can be accessed here.
CFM – Brazilian Federal Council of Medicine
Judicial decision addresses dispute regarding medical specialist title
The rapporteur of the 8th Panel of the Regional Federal Court of the 1st Region (TRF-1) ruled in favor of the Interlocutory Appeal filed by the Brazilian Federal Council of Medicine (“CFM”) to prevent doctors from publicizing lato sensu postgraduate degrees in medicine.
The judge agreed with the opinion of the CFM that publicizing a lato sensu postgraduate degree can mislead the patient to believe that such professional is a specialist.
As a result, such type of announcement has been forbidden until the trial court issues a decision. More information about the decision can be accessed here.
LEGISLATION
Salvador city law creates municipal policy for distribution of cannabis medicines and products
In March 2023, the city of Salvador approved Law No. 9,663/2023, which provides for the municipal policy regarding the use of cannabis for medicinal purposes and cost-free distribution of prescribed cannabis-based medicines by SUS.
The new policy follows in the innovative footsteps of the state of São Paulo, which published the first Brazilian law that authorized the distribution of cannabis products through SUS, in 2022.
In fact, the city of Salvador innovated even further than São Paulo, by including not only the distribution of cannabis-based medicines in the policy, but also the distribution of Cannabis Products registered with Anvisa in accordance with DRC 327/2019, which will result in a wider range of treatment options through SUS.
Additionally, such initiative from the city of Salvador further stimulates the trend that, due to the lack of federal regulations, municipalities can implement local policies that provide for the distribution of cannabis-based medicines and products through the SUS.
ANVISA – Brazilian National Health Regulatory Agency
Anvisa consolidates food additives regulations
On March 08, 2023, Anvisa published a consolidated document of regulations that provide for the use of additives and co-formulants in the food industry.
The 67 previous acts had been consolidated in RDC No. 778/2023, RDC No. 779/2023 and Normative Instruction No. 211/2023. Anvisa seeks to simplify the comprehension and research of regulations that provide for the use of food additives.
It is worth highlighting that the development of a regulatory framework of the food industry is included in Anvisa’s 2021-2023 Regulatory Agenda. Since the publication of Decree 10,139/2019, Anvisa has concentrated efforts in improving and consolidating its regulatory framework.
ANVISA – Brazilian National Health Regulatory Agency
Resolution amends provisions regarding medical devices
On March 01, 2023, RDC 777/2023 was published, amending RDC 751/2022, which provides for:
- risk classification;
- notification and registration systems; and
- requirements for labeling and instructions for use of medical devices.
The main changes are relating to criteria that can lead to suspensions regarding medical devices, and to provisions relating to the disclosing of amendments to registries with Anvisa.
With regard to the suspension of the production, import, distribution, trade and use of medical devices, Article 39 of RDC No 751/2022 encompassed a wider range of events that could lead to such suspensions. After the changes, such procedures can only be suspended in the event that Anvisa identifies:
- health risk due to irregularities in the product;
- irregularities in the production process of the product;
- lack of a certificate of conformity; and
- conditions that differ from what was approved by Anvisa.
Regarding the disclosing of registry amendments, the former wording of Article 22 of RDC no. 751/2022 provided that the updated data had to be published on the Anvisa website within 30 days. The new wording, however, exempts Anvisa from such deadline.
The amendments entered into force on March 01, 2023.
ANS – Brazilian Supplementary Healthcare Agency
New regulations regarding technical provisions by health care operators
On March 02, 2023, Resolution 574/72 was published, which:
- provides for new criteria regarding technical provisions to be adopted by health care operators; and
- repeals the Normative Resolutions No. 393/2015, No. 442/2018 and No. 476/2021, which previously regulated the matter.
The main changes concern the premium insufficiency rate (“FIC”), which can now be calculated on the basis of information relating to the last 12 or 24 months, applying the lowest rate for the calculation of the Provision of Insufficient Premiums (PIC). Before the Resolution, the calculation of the FIC had to be based on a 12-month period.
ANS – Brazilian Supplementary Healthcare Agency
ANS implements Integrated Environmental Governance and Responsibility Policy
On March 22, 2023, Resolution 82/2023 was published, which established the goals, principles, guidelines and duties regarding the implementation of the Integrated Environmental Governance and Responsibility Policy (ESG) within the context of ANS.
The policy is in line with the goals established in the regulatory agenda and the strategic planning of the ANS for the period of 2023-2025. The initiative proposes a different allocation of public services, focused on reducing operational costs and fostering corporate governance and sustainable development.
For more informations, please visit our client alert on this topic.
ANS – Brazilian Supplementary Healthcare Agency
Changes in the regulation on Certification Program for Best Practices of Health Care Operators
On March 23, 2023, Resolution 572/2023 was published, in order to amend provisions of Resolution 506/2023, which established the Certification Program for Best Practices of Health Care Operators.
The changes introduced by the Resolution provide for:
- audit procedures to certify the operator;
- cases involving the loss of the certification issued by the ANS; and
- the provision of a Guideline to Good Practices at the end of the document.
ANS – Brazilian Supplementary Healthcare Agency
Resolution adjusts ligation surgery and vasectomy regulations to current legislation
On March 22, 2023, ANS published Resolution No. 576/2023, which amends the regulation regarding mandatory coverage of female sterilization (tubal ligation) and male sterilization (vasectomy) procedures, in order to adapt the rules to Law No 14,443, published on September 05, 2022.
The main changes concern:
- reduction of the minimum age (to 21 years old) for men and women to undergo sterilization procedures voluntarily; and
- exclusion of mandatory consent from the spouse or partner for a person to undergo a tubal ligation procedure.
MS – Brazilian Ministry of Health
New version of Mais Médicos promises incentives to professionals
On March 21, 2023, the Federal Government published Provisional Measure No. 1,165/2023, which implemented Brazil’s National Strategy for the Training of Health Specialists, within the scope of the Mais Médicos program.
The Provisional Measure aims to provide incentives for the training of physicians to assist in the primary health care network, particularly in regions that are located further from large metropolitan centers. In addition to physicians, the Provisional Measure also provides for other specialized professionals, dentists and nurses.
According to the minister of Education, Mais Médicos will offer 6,000 positions for physicians across Brazil.
PUBLIC CONSULTATIONS AND HEARINGS:
ANVISA – Brazilian National Health Regulatory Agency
Anvisa initiates consultation on list of referenced medicines
On March 20, 2023, Anvisa initiated a consultation to obtain contributions regarding RDC 35/2012, which provides for criteria to request, include or exclude medicines from the List of Referenced Medicinal Products.
Anvisa seeks to obtain information that can assist in the assessment of potential regulatory changes to RDC No. 35/2012, in order to optimize the procedure of requesting, inclusion and exclusion of medicinal products from the list.
Contributions can be submitted by April 19, 2023, through this link.
MAPA – Ministry of Agricultura, Livestock and Food Supply
MAPA seeks contributions to the proposed regulation of Law for the Self-Monitoring of Private Agents
On March 21, 2023, Ordinance No. 769/2023 was published, which requested contributions to discuss the proposed regulation regarding the Law for Self-Monitoring of Private Agents (Law No. 14,515/2022).
Law No. 14,515/2022 provides for self-monitoring programs within the scope of private agents governed by the Defense of Agribusiness and Livestock Raising, as well as the structuring of internal procedures by such agents within their respective sectors.
MAPA – Ministry of Agricultura, Livestock and Food Supply
Proposed regulation on agricultural aviation subject to public consultation
On March 22, 2023, Ordinance No. 769/2023 was published. The Ordinance was the subject of a public consultation to obtain contributions on the proposed Decree-Law No. 917/1969, which provides for Brazil’s agricultural aviation.
MAPA seeks to adjust the Decree to the current Brazilian agricultural landscape, given that Brazil has the second largest fleet of agricultural aircrafts in the world, an industry that has been transformed by technological advances.
One of the changes that MAPA intends to implement involves the creation of new penalties, as well as the establishment of specific administrative proceedings regarding such penalties.
Contributions can be submitted by May 24, 2023, through this link.
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