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.
Enjoy reading!
Demarest’s Life Sciences Team
ANVISA – Brazilian National Health Regulatory Agency
ANVISA publishes the 2023-2026 Regulatory Result Evaluation Schedule
On February 16, 2023, the 2023-2026 Regulatory Result Evaluation (“ARR”) Schedule was published, which consists in evaluating the effects of the enactment of certain normative acts, considering the scope of the originally intended purposes and other impacts on the market and society, as a result of their implementation.
The Schedule includes the analysis of several regulations published by ANVISA over the last few years and encompasses the most diverse sectors, such as health products, cosmetics, medicines, pesticides, and others.
The Guiding Document of the 2023-2026 ARR Schedule and the Monitoring Dashboard have been released for monitoring purposes.
ANVISA – Brazilian National Health Regulatory Agency
“E-Participa” report published on the review process for legislation of cannabis products
Last February, ANVISA published the “E-Participa” report, compiling contributions sent between October and November 2022 for the purposes of reviewing RDC 327/2019, which provides for Cannabis products for human medicinal use.
The report, which is intended to provide transparency to those interested on the matter, is part of the actions being taken by the Agency to review the rule. This step, in particular, has enabled:
i) a greater understanding by ANVISA’s technical areas of the needs and realities of those interested on the matter; and
ii) the compilation of technical information to support the process of reviewing the rule.
Although all these contributions are extremely relevant to the sector, ANVISA clarifies that it will continue to carry out all necessary technical analyses to support any decisions related to possible changes in the legislation.
ANVISA – Brazilian National Health Regulatory Agency
Working Group in the state of São Paulo was established to ensure the implementation of the law that authorized the supply of medicines derived from cannabis by SUS
On February 14, 2023, SS Resolution No. 18/2023 of the Health Department of the state of São Paulo was published, by means of which a Working Group was established to implement the state policy of free supply of medicines formulated from cannabidiol-based plant derivatives, on an exceptional basis by the Executive Branch, in public, state, and private health units affiliated to the Brazilian Unified Health System (“SUS”).
The implementation of this Working Group is in line with the provisions of State Law No. 17,618/2023, passed in January 2023. For more information on the subject, see the previous issue of the Life Sciences Newsletter.
ANVISA – Brazilian National Health Regulatory Agency
Recent decision authorizes Association to cultivate cannabis and produce medicinal oil
In a decision rendered by the 2nd Federal Court of the state of Santa Catarina, the Medicinal Cannabis Association of Santa Catarina (“Santa Cannabis”) was authorized to cultivate cannabis and subsequently produce medicinal oil for the treatment of members who have a medical referral for its use. The lawsuit is a public civil action filed against the Government and ANVISA.
The decision also allowed Santa Cannabis to import the necessary seeds for planting, which enables the Association to carry out further research with its patients. The decision includes positive precedents from the Superior Court of Justice (“STJ”), which reinforces the permission granted.
Click here to read the decision in full.
ANS – Brazilian Supplementary Healthcare Agency
COSAÚDE analyzes the inclusion of cancer drugs in the ANS List
On February 14, 2023, the Brazilian Supplementary Healthcare Agency (“ANS”) held the 13th technical meeting of the Committee for Updating the List of Health Events and Procedures in Supplementary Health (“COSAÚDE”), in which new proposals for incorporation in the list of mandatory coverages of health care plan operators were discussed.
At the meeting, the following drugs used for the treatment of cancer were analyzed:
i) olaparib (in combination with bevacizumab for the treatment of advanced epithelial ovarian carcinoma); and
ii) darolutamide (for the treatment of hormone-sensitive metastatic prostate cancer in combination with docetaxel).
The proposals for the inclusion of these drugs will be submitted by the ANS to public consultation, on a date yet to be announced, to enable the participation of society in the process of updating the list.
ANS – Brazilian Supplementary Healthcare Agency
STJ decision validates unilateral termination of health plan in case the company is inactive
On January 31, 2023, the 3rd Panel of the Superior Court of Justice (“STJ”) unanimously decided that if a company that contracted private health insurance by association becomes inactive, the unilateral termination of the contract by the health insurance provider must be authorized.
According to the Panel’s understanding, the beneficiaries of the private health insurance by the association are connected to a legal entity, whose inactivity leads to the termination of such connection and hinders the maintenance of the contracted health insurance.
Nancy Andrighi, the reporting Justice of the appeal, emphasized that the bond between the beneficiary of the private health insurance by association and the contracting legal entity is a condition for the insurance to be valid. Therefore, if the company is inactive, the exclusion or suspension of health care assistance to the beneficiaries of the private health insurance by association is authorized.
Read the decision in full here
ANS – Brazilian Supplementary Healthcare Agency
Grace Period Portability: more than 300 thousand consultations were carried out in 2022
The ANS’ Health Plan Guide issued a report to monitor portability protocols, in which it was registered that the interest for grace period portability remained stable in 2022, registering a slight decrease of 0.83% in comparison to 2021.
According to the report, the main reasons mentioned by beneficiaries regarding the desire to carry out grace period portability in 2022 include:
i) the search for a cheaper plan;
ii) the search for a network of better-quality health care providers; and
iii) contract cancellation.
ANS – Brazilian Supplementary Healthcare Agency
ANS includes medication for spinal muscular atrophy in its list of mandatory coverages
On February 06, 2023, the collegiate board of the ANS approved the incorporation of the following technologies to the list of health procedures and events:
i) Onasemnogene abeparvovec (Zolgensma®) – for the treatment of pediatric patients up to 6 months of age with Spinal Muscular Atrophy (SMA) type I, who are off invasive mechanical ventilation over 16 hours per day;
ii) Dupilumab – for the treatment of adult patients with severe atopic dermatitis with a referral for systemic treatment and who have failure, intolerance or contraindication to cyclosporine;
iii) Zanubrutinib – for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapeutic treatment; and
iv) Romosozumab – for the treatment of postmenopausal women with osteoporosis, aged 70 and older, who have not responded to drug therapy.
ANS – Brazilian Supplementary Healthcare Agency
STF overturns state law that allows payment of health plans with Pix and credit cards
On February 22, 2023, when judging the Direct Action for Declaration of Unconstitutionality (“ADI”) 7023, the Federal Supreme Court (“STF”) declared the unconstitutionality of Rio de Janeiro State Law No. 9,444/2021, which expanded the forms of payment for private health and dental care plans, obliging operators to allow payments to be carried out via credit card, digital payment slip, and Pix.
According to the position of the STF, the rule took on the powers of the Federal Government to legislate on Civil and Commercial Law and on insurance policy and, therefore, violated article 22, I, and VII, of the Federal Constitution.
MAPA – Ministry of Agriculture, Livestock and Food Supply
Eight new bioinputs registered by MAPA
MAPA has registered eight new low-impact pesticides as reported by Act No. 05 in the Federal Government’s Official Gazette, which was published on February 13, 2023. The bioinputs are composed of organic materials harmless to humans and other animals. The new registered products are specifically composed of Beauveria bassiana, Bacillus licheniformis, Bacillus subtilis, Trichoderma harzianum, Trichoderma viride; in addition to baculovirus of Spodoptera frigiperda, specific for caterpillars.
Another novelty was the registration of the herbicide containing the active ingredient Thiafenacil, previously unknown in Brazil. The product is widely used for direct planting procedures, mainly in the agricultural plantations of cotton, beans, corn and soybeans.
It is worth mentioning that all registered products were analyzed and approved by ANVISA, the Brazilian Institute of Environment and Renewable Natural Resources (“IBAMA”), and MAPA.
MAPA – Ministry of Agriculture, Livestock and Food Supply
Simplified access to credit lines is discussed with fintechs and companies
MAPA has held meetings with representatives of the carbon, biofuels, and fintech sectors to discuss ways to simplify access to special credit lines for producers committed to sustainability in the field.
MAPA’s goal is to ensure that sustainable production is increasingly attractive to rural producers, by offering additional advantages and discounts. Fintechs have stated in the meetings that the volume of credit resources would currently be more advantageous than variable interest rates. The injection of funds would cause self-regulation in the market, generating competitiveness among companies.
MAPA – Ministry of Agriculture, Livestock and Food Supply
Dynamic Reports Platform is created to integrate data on agriculture and livestock
The Dynamic Reports Platform was launched by the Observatory of Brazilian Agriculture, aiming to promote simplified access for users seeking information related to agriculture and livestock. The provision of solid data from the field enables an improved monitoring of the sector, which facilitates support to production chains in a more efficient way.
By accessing the website, the user can browse through topics and obtain versatile reports, including, among others: Sustainable Agribusiness and Environment, Land Issues, Foreign Trade, Rural Credit, Fertilizers, Indicators, Livestock, Agricultural Products, National Soil Program (“PronaSolos”) and Agricultural Climate Risk Zoning (“ZARC”).
CFM – Brazilian Federal Council of Medicine
Decision determines that physicians with postgraduate degrees cannot be advertised as specialists
On February 22, 2022, the Federal Justice Court of the First Region (“TRF1”), accepted an appeal filed by the Federal Council of Medicine, when it ruled that physicians with postgraduate degrees cannot be advertised as specialists.
According to the Court, this is an ethical prohibition, arising from a provision inserted in CFM Resolution No. 1,974/2011 and also provided for in Decree-Law No. 4,113/1942, which, among its provisions, regulates the advertising of physicians. Furthermore, the decision stressed that the advertising of physicians, when carried out in this manner, has the potential to “deceive possible patients that they are specialists”.
Click here to read the decision in full.
ANVISA – Brazilian National Health Regulatory Agency
New Resolution updating the list of Brazilian Common Denominations published
On February 22, 2023, ANVISA published RDC 775/2023, which provides for the updated list of Brazilian Common Denominations (“DCBs”), including 16 new denominations and the change of three other DCBs.
The DCB refers to the denomination of the drug or pharmacologically active ingredient approved by the federal agency in charge of health regulations, under Law No. 6,360/1976. In addition, the DCB currently includes the denomination of inactive inputs, hyperimmune serums and vaccines, radiopharmaceuticals, medicinal plants, homeopathic and biological substances.
The new rule entered into force on the date of its publication and the updated list of DCBs can be accessed via this link.
ANVISA – Brazilian National Health Regulatory Agency
Updated rules for regularization of medical devices enter into force
On March 01, 2023, RDC 751/2022, entered into force, which updates the rules for medical devices, providing for risk classification, notification and registration schemes, labeling requirements and instructions for use for these devices.
The rule, which was published in September 2022, replaces RDC 185/2001 and is extremely relevant for the industry, since it establishes new and more specific definitions for these products. For more details, see our Life Sciences Newsletter issued in October 2022.
In addition, on March 01, 2023, RDC 777/2023, was published, which amended RDC 751/2022 to include, among other provisions, that:
i) The rule is not applicable to custom-made medical devices, which are subject to the provisions of RDC 186/2019;
ii) ANVISA can suspend the manufacture, import, distribution, trading, and use of the medical device in case of health risks; and
iii) ANVISA can, at any time, request information or clarifications prior to the decision to cancel the notification or irregular medical device registration.
RDC 777/2023 entered into force on the date of its publication.
ANS – Brazilian Supplementary Healthcare Agency
Individual business owners allowed to jointly contract a collective corporate private health care plan.
On February 01, 2023, ANS Normative Resolution No. 570, was published, amending RN Normative Resolution No. 557/2022, which provided for the classification and characteristics of private health care plans and regulated their contracting. In addition, the resolution provided for the contracting of a collective corporate private health care plan by individual business owners.
The new Resolution amended article 29 of the former Resolution to exclude the prohibition previously stated in paragraph 2 and, consequently, allow individual business owners to jointly contract a collective corporate private health care plan.
ANS – Brazilian Supplementary Healthcare Agency
New rules for incorporation of Technical Provisions of Health Care Plan Operators published
On March 02, 2023, ANS Normative Resolution No. 574/2023 (“RN No. 574/2023”) was published, establishing new criteria for the incorporation of Technical Provisions to be followed by Private Health Care Plan Operators. Benefits administrators are not subject to this RN.
For more information, see our Client Alert.
CONCEA – National Council for the Control of Animal Experimentation
Use of animals for testing and research of cosmetics, perfumes, and personal hygiene products prohibited
On March 01, 2023, Normative Resolution 58/202 of CONCEA was published, which provides for the prohibition of the use of vertebrate animals, except humans, in scientific research, development, and control of personal hygiene products, cosmetics, and perfumes that use in their formulations ingredients or compounds that are already scientifically proven to be safe and effective.
According to the new rule, in cases where the formulas are new and there is no previous proof of safety or efficacy, the use of alternative methods recognized by CONCEA in the development and quality control of these products is mandatory.
The Resolution entered into force on the date of its publication.
PUBLIC CONSULTATIONS AND HEARINGS
ANVISA – Brazilian National Health Regulatory Agency
Public Call Notice published for the collection of data on similar drugs
On February 07, 2023, Public Call Notice 19/2023 was published, aiming to collect information from the pharmaceutical industry on the worldwide registration and regulatory status of similar drugs without reference medication, including the single similar drugs available in the market.
According to the published Notice, all companies holding synthetic drug registrations that meet one of the following conditions can contribute to ANVISA:
i) are classified as single similar drugs available in the market (“SUM”) and have not yet been considered compliant with RDC No. 134/2003 or RDC No. 675/2022;
ii) are classified as similar, have not yet been considered compliant with RDC 134/2003 or RDC 675/2022, and do not have, to date, a reference medication appointed on the List of Reference Drugs published by ANVISA; or
iii) are classified as similar, new or generic, and have been, at some time, listed on the List of Reference Drugs published by ANVISA, but have been withdrawn for evaluation and have not returned to the market so far.
ANVISA has clarified that, based on this survey, it intends to carry out a general analysis on whether these drugs are present in other regulated markets or not.
Interested parties may submit the requested information by May 08, 2023. Contributions can be submitted by using the form provided in the Notice.
Related Partners
Related Lawyers
Beatriz Cavicchioli de Marino
Leticia Barhum Hailer
Related Areas
Agribusiness Public and Regulatory Law Life Sciences Insurance, Reinsurance, Health and Private Pension
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