Life Sciences Newsletter no 11 – February 2022

Check out our Life Sciences Newsletter for the month of February, which gathers information on recent and upcoming regulation and news related to the health and agriculture sector in Brazil.

For more information, contact our team.

Enjoy reading!
Demarest Life Sciences Team

Legislations

ANS – Brazilian Supplementary Health Agency

New Law enacted that expands coverage of health insurance plans and establishes deadline to be incorporated into ANS

After a long discussion within the scope of  Brazil’s Congress and Executive Branch, on March 3, 2022, Law No. 14.307 was published, amending Law No. 9,656/1998, which provides for private health care plans and insurance.

Among the changes, we highlight the establishment of a term of 180 days, which can be extended for another 90 days, for the ANS to complete the analysis of the process of inclusion of procedures and medicines in the list of mandatory healthcare procedures, as well as the mandatory supply of cancer medicines to be administered orally and for home use, including those whose treatment commences in hospital. In addition, the “Commission for Updating the List of Supplementary Health Procedures and Events” will be created to assist the Agency in future updates.

ANVISA – Brazilian Health Agency

ANVISA authorizes remote inspection of imported products in ports and airports

After a long discussion within the scope of  Brazil’s Congress and Executive Branch, on February 09, 2022, ANVISA published RDC No. 597, which provides for remote inspections of imported goods and products subject to health inspection at ports and airports.

For more information, refer to our Client Alert on the subject.

ANVISA – Brazilian Health Agency

ANVISA updates sanitary measures for the port sector, platforms, and vessels

On February 11, 2022, ANVISA published RDC No. 605, amending RDC 584/2021, which provides for sanitary measures regarding the operation and the loading and unloading of cargo vessels and platforms located in Brazilian jurisdictional waters and from cargo vessels.

The purpose is to improve safety criteria in circulation areas, focusing on the vaccination of crew and port workers, by requiring that tests for Covid-19 be carried out in deadlines that are shorter and closer to boarding times (48 hours prior).

ANVISA – Brazilian Health Agency

ANVISA updates the list of substances subject to special control

On February 9, 2022, RDC No. 598, which updates the List of Narcotic, Psychotropic, Precursor and Other Substances under Special Control of Ordinance SVS/MS No. 344/1998.

The new substances are 1B-LSD, 1P-LSD, 5C-MDA-19, 5F-MDA-19, ADB-FUBIATA, ALD-52, and MDA-19. In addition, Addendum 16 has been added to the F2 list.

ANVISA- Brazilian Health Agency

ANVISA publishes resolution on the simplified analysis of temporary clinical research

On February 16, 2021, ANVISA published  RDC No. 601, of February 09, 2022, which provides for simplified analysis of petitions for consent in the clinical research process, on an exceptional and temporary basis. The purpose of such measure is to make the procedure for releasing petitions for consent faster and more efficient, in light of the current pandemic scenario.

For more information, refer to our Client Alert on the subject.

ANS – Brazilian Supplementary Health Agency

ANS adds three procedures to the list of mandatory coverage

On February 14, 2022, ANS published RDC nº 480/2022, which introduces new procedures to the list of minimum mandatory coverage by health insurance plans.

The three new procedures are: “Mycobacterium leprae (Hansen’s Bacillus), detection of antibiotic resistance by PCR”; “Mycobacterium leprae (Hansen’s Bacillus), IgM, antibodies (rapid test)”; and “Mycobacterium leprae (Hansen’s Bacillus), Real-time PCR Research”.

ANVISA – Brazilian Health Agency

ANVISA consolidates rules related to the food sector

On February 16, 2021, Anvisa published three resolutions in regard to the food sector, consolidating guidelines established in Decree 10,139/2019.

RDC No. 602 of February 10, 2022, repeals a total of 16  outdated rules; RDC No. 603 of February 10, 2022, reviews and consolidates the topic of Free Sale Certificate for Food Exports (CVLEA); and RDC N˚. 604 of February 10, 2022, deals with the mandatory enrichment of salt with iodine, and enrichment of wheat and corn flour with iron and folic acid.

ANS – Brazilian Supplementary Health Agency

Publication of new rule that creates Citizen Information Service

On February 25, 2022, Rule RA No. 75  was published, which provides for active and passive transparency mechanisms within the scope of the ANS, institutes the Citizen Information Service (“SIC”) of the ANS, classifies information held by the ANS according to degrees of secrecy, and provides for it’s the processing of such data.

The purpose is to provide greater transparency and access to such information within the scope of the Agency. The SIC will be implemented as an orderly set of actions aimed at responding to citizen requests for access to information. In addition, the ANS will provide public access to a variety of data relevant to the public on its website.

News

ANVISA – Brazilian Health Agency

ANVISA approves the registry of the first self-test for Covid-19

On February 17, 2022, ANVISA approved the first self-test for the Coronavirus, the Novel Coronavirus (2019-nCoV) Antigen Rapid Test, by the company CPMH Comércio e Indústria de Produtos Médico-Hospitalares e Odontológicas Ltda.

As a result, all products authorized by ANVISA can now be marketed directly to the target audience. Parameters were established in RDC N˚ 595, of January 28, 2022.

ANVISA – Brazilian Health Agency

Three new Cannabis-based medicinal products authorized

ANVISA approved, on February 21, 2022, three more Cannabis-based medicinal products. Such products are “Cannabidiol Belcher 150 mg/mL”, “Cannabidiol Aura Pharma 50 mg/mL”, and “Cannabidiol Greencare 23.75 mg/mL”.

As a result, the list of products contained in RDC 327/2019 was updated, totaling fourteen products approved since the Rule was issued.

 

Report on minimum wage for nurses is approved by the Chamber Working Groups

On February 23, 2022, the Working Group of the House of Representatives approved minimum monthly wage amounts for nursing professionals. According to the text, nursing assistants should have the value fixed at BRL 2,375.00; nursing technicians at BRL 3,325.00; and nurses at BRL 4,750.00.

The text now needs to go through further committees of the House of Representatives before advancing to the plenary.

Public Consultations and Hearings

MAPA – Ministry of Agriculture, Livestock and Food Supply

MAPA opens public consultation on rules regarding vegetable seedling

On February 22, 2022, the MAPA released a public consultation on the proposed ordinance that aims to establish standards and criteria for production, certification, technical responsibility, processing, repackaging, storage, sampling, analysis, marketing, and use of vegetative propagation material and seedlings.

Interested parties will have 60 days from the publication date to submit their suggestions. Suggestions can be sent through here.

In order to access, it is necessary to register on this link.

ANS – Brazilian Supplementary Health Agency

New public consultation on the rules of Monitoring of Healthcare Assistance Risk is available

On February 21, 2022, the ANS made available a public consultation for a proposal to amend DIPRO Normative Instruction No. 50/2016, which deals with the enhancement of monitoring rules for operators, with regard to the Monitoring of Healthcare Assistance Risk.

The deadline for submitting contributions is April 06, 2022. Suggestions can be sent through this link.

Bills

ANS – Brazilian Supplementary Health Agency

Bill aims to define ANS’s list of procedures as illustrative

Bill 416/2022,  in progress in the House of Representatives, seeks to make the list of procedures and events by the ANS illustrative, rather than exhaustive.

The purpose is to emphasize that the list provided for in Law No. 9,656/1998 deals only with mandatory minimum coverage and should be used as a basic reference and not exhaustively.

The Bill is currently awaiting an Order from the Chairman of the House of Representatives.

The deadline for submitting contributions is April 06, 2022. Suggestions can be sent through this link.