[vc_row][vc_column][vc_column_text]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[/vc_column_text][vc_empty_space height=”40px”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]
ANVISA – National Health Regulatory Agency
Trade of cannabis products in Brazil boosted by favorable rulings and new registrations
Throughout November, there was a noticeable market movement toward stimulating the trade of cannabis products. Since 2019, ANVISA has registered 23 cannabis products.
It is worth highlighting the decision of the Fifth Panel of the Superior Court of Justice, which settled the comparative case law on home cultivation of cannabis, establishing that home cultivation is allowed, provided that it complies with the limits established in the medical prescription. The reporting judge decided that it is unreasonable to prohibit cannabis cultivation for medicinal purposes, given that health is a fundamental right.
In addition, another cannabis product, whose cannabidiol dose amounts to 100 mg/ml, was registered by ANVISA. The new cannabis product will be sold in Brazilian pharmacies and requires a medical prescription.
ANVISA – National Health Regulatory Agency
New landscape regarding health measures against the COVID-19 pandemic
Throughout November, ANVISA established new health measures to combat the COVID-19 pandemic more efficiently in Brazil.
Among such measures are:
- Approving the sale of “Paxlovid”, a medicine against COVID-19, in pharmacies and private hospitals, upon medical prescription. The medicine had been registered by ANVISA in May 2022, but before the new approval, had only been dispensed through the Brazilian Unified Health System (“SUS”).
- Approving registration of the first bivalent vaccines in Brazil, as a temporary emergency countermeasure. Bivalent vaccines protect individuals against more than one strain of the COVID-19 virus and will be essential in order to protect the population against the Omicron variant.
- Adoption of new health measures in airports and airplanes: mandatory use of masks in such environments, in addition to periodic maintenance of indoor climate control systems.
- Adoption of new health measures in the procedure of boarding and disembarking of a ship’s crew, such as presenting a mandatory vaccination certificate or undergoing recurring COVID-19 diagnostic tests.
ANVISA – National Health Regulatory Agency
Public consultation addresses modernization and cost reduction for biosimilars
On November 07, 2022, ANVISA published a notice of public consultation to receive contributions regarding the development of biosimilars. Contributions can be submitted by January 09, 2022.
ANVISA’s goal is to analyze the main obstacles of the sector in order to improve the development of biosimilars, through which it would be possible to produce more modern and lower-cost medicines in Brazil, and consequently improve the regulatory framework on the topic, currently regulated by RDC No. 55/2010.
ANS – Brazilian Supplementary Healthcare Agency
STF ends judicial discussions regarding ANS’ list of procedures
In a virtual session held on November 11, the full Federal Supreme Court decided to dismiss actions that sought to declare the unconstitutionality of Normative Resolution No. 465/2021 and Laws No. 9,961/2000 and 9,656/1998, which limited the coverage of health care plans to events and procedures listed by ANS.
The majority of the STF understood that the actions lost their object due to the publication of Law 14,454/2022, which settled the dispute regarding which procedures needed to be mandatory in the coverage of health care plan operators. Law 14,454/2022 also established that events and procedures not listed by ANS can be covered by health care plans if they are scientifically proven to be effective or recommended by the National Committee for Health Technology Incorporation (CONITEC) or by internationally renowned health technology assessment bodies.
MAPA – Ministry Of Agriculture, Livestock and Food Supply
MAPA and EMBRAPA carry out measures to stimulate bioinputs market
Due to the surge in the use of traditional agricultural pesticides, the search for bioinputs increased significantly in 2022. In addition, MAPA has increasingly carried out measures aimed at stimulating the growth of the sector.
In this regard, during November:
- A Technology Offering Notice was published aiming to select companies to produce and market the “Tricovab” bioinput on a large scale. Tricovab is effective to control the pest that affects cocoa production in the country. The pesticide is expected to inhibit the pest in the soil by 99%.
- In addition, Embrapa inaugurated the Multiuser Laboratory for Research and Development of Bioinputs (“BioFabLab”). The new laboratory will enable the production of biological inputs that facilitate farmers’ access to new products and stimulate the development of new agricultural pesticides.
[/vc_column_text][vc_empty_space height=”40px”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]LEGISLATION
ANVISA – Brazilian National Health Regulatory Agency
ANVISA authorizes free trade of ethanol
On November 17, 2022, RDC No. 760/2022 was published, which authorizes the free trade and donation of 70% ethanol, exceptionally and temporarily.
The measure was authorized for 90 days, as an exception due to the recent increase in COVID-19 cases. The same measure was previously authorized by ANVISA, but was not renewed after it expired.
As a result, the trade of ethanol can be carried out with fewer restrictions during this period, in contrast to the previous landscape in which direct sale to the population was prohibited.
MS – Brazilian Ministry of Health
Proposal for annual funding increase for hospitals accredited to SUS approved by the Federal Senate
On November 08, 2022, the Federal Senate approved Bill No. 468/2018 (“PL”), which provides for the annual increase in compensation for hospitals that enter into accreditation agreements with the Brazilian Unified Health System (“SUS”).
The PL amends the wording of the “Organic Health Law”, in order to ensure that necessary costs are duly covered and the quality of procedures and services provided through SUS is maintained. As a result, the PL intends to prevent an outdated table of costs from affecting health services provided through SUS (in comparison to real expenses incurred in such services provided through SUS), especially in regard to Government funding to cities and states.
The Bill is currently pending before the House of Representatives.
MS – Brazilian Ministry of Health
Bill that regulates telehealth approved by the Federal Senate
On November 29, 2022, the Federal Senate approved Bill No. 1998/2020 (“PL”), which provides for the regulation of telehealth services. The amendments proposed in the approved text will now be subject to approval by the House of Representatives.
The proposed amendments concern occupational health examinations, patient data protection, and the exclusion of mandatory price equalization between remote and in-person services.
Throughout the COVID-19 pandemic, telehealth services were authorized on an emergency and temporary basis, but since then, the topic lacks regulation at the federal level. The PL provides for the general principles of telehealth and medical autonomy standards for using such tools.
MS – Brazilian Ministry of Health
Contracts for services to SUS extended
On November 29, 2022, Provisional Measure No. 1,142/2022 (“MP”) was published, authorizing the extension of contracts for services within the scope of the Ministry of Health.
Contracts addressed by the MP refer to services provided by health professionals to carry out their practice in federal hospitals and national institutes in the State of Rio de Janeiro, due to the exceptional public interest of the region. Such extension will be implemented according to the budget of the state.[/vc_column_text][vc_empty_space height=”40px”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]PUBLIC CONSULTATIONS AND HEARINGS:
ANVISA – Brazilian National Health Regulatory Agency
Clinical trials involving medical devices subject to public consultation
On November 03, 2022, ANVISA opened a public consultation to receive contributions regarding the review of RDC 548/2021 (“RDC”), which provides for clinical trials involving medical devices. Contributions can be submitted by December 19, 2022.
As part of ANVISA’s Regulatory Agenda for 2021-2023, the discussion on the topic is aimed at aligning the provisions established by the RDC to the needs of the sector.
ANS – Brazilian Supplementary Healthcare Agency
Mandatory coverage of COVID-19 and Monkeypox tests analyzed in public consultation
On November 09, 2022, a public consultation was opened to receive contributions from the market regarding the recent inclusion of diagnostic testing for COVID-19 and Monkeypox in the list of mandatory events and procedures of ANS, through Normative Resolutions No. 478/2022 and 544/2022.
Mandatory coverage of such tests significantly impacted operations carried out by healthcare operators and, as a result, the topic will be analyzed by the ANS. Contributions can be submitted by November 29, 2022.
ANS – Brazilian Supplementary Healthcare Agency
Public consultation initiated for contributions regarding “Preliminary Intermediation Notification” rules
On November 11, 2022, a public consultation was initiated regarding the new rules of the “Preliminary Intermediation Notification” (“NIP”). Such procedure was designed to mediate disputes between healthcare plan users and operators.
The new rule extinguishes the residual classification phase of the NIP, providing more agility to the analysis of claims filed through the ANS service channel. Contributions can be submitted by December 28, 2022, through the ANS official website.
MAPA – Ministry of Agriculture, Livestock and Food Supply
Amendments to pesticides legislation analyzed
On October 27, 2022, MAPA initiated a public consultation to receive contributions regarding a normative proposal that establishes parameters for the registration of pesticides, and any related components or products for crops with insufficient phytosanitary support and low use, in addition to providing for the maximum allowed residue limit.
The consultation will remain open for 90 days and contributions will be analyzed by a technical group, coordinated by the General Coordination of Pesticides and Related Products, and joined by other competent bodies for the registration of pesticides. [/vc_column_text][vc_empty_space height=”40px”][/vc_column][/vc_row]
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