[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
Monkeypox diagnostic tests approved in Brazil
ANVISA has been analyzing several requests on a priority basis for the registration of monkeypox diagnostic tests, in light of the increasing numbers of the disease being reported.
Thus far, two diagnostic tests have been approved: Kit Molecular Multiplex OPXV/MPXV/VZV/RP Bio-Manguinhos and Kit Molecular Monkeypox (MPXV) Bio-Manguinhos, both manufactured by Fundação Oswaldo Cruz. The requirements and criteria analyzed are provided for in RDC No. 36/2015 and the analysis takes about 40 days.
Within the scope of public health, the Ministry of Health has already extended the testing for the disease to 31 laboratories in different locations in Brazil.
Anvisa – National Health Regulatory Agency
New nutrition labeling comes into force
On October 09, 2022, amendments to RDC No. 429/2020 and IN No. 75/2020 entered into force, setting new requirements for nutrition labeling, which must be complied with for foods produced after that date. .
Among the changes are the standardization of information design, the identification of total and added sugars, as well as the new front-of-package nutrition labeling, which must explicitly state whether the amount of added sugars, saturated fats or sodium is equal to or greater than the parameters set in the legislation.
For more information on the topic, read our Client Alert.
Anvisa – National Health Regulatory Agency
Regulation on cosmetics and personal hygiene products enters into force
On October 03, 2022, RDC No. 752/2022 entered into force , establishing sanitary rules on personal hygiene products, cosmetics and perfumes.
Among the main innovations are changes to labeling, registration procedures and microbiological control standards.
In order to provide clarifications regarding the microbiological specifications of the product, ANVISA published Technical Note 31/2022, which explains how this procedure will be carried out: (i) such specifications must be submitted for products that are susceptible to biological contamination, and (ii) a technical justification must be submitted for products with low susceptibility to contamination, in accordance with ISO 29621:2017.
ANS – Brazilian Supplementary Healthcare Agency
D-TISS dynamic dashboard database updated
On October 03, 2022, the ANS updated the database linked to the D-TISS tool, a digital domain that contains information related to the market value of fees for numerous services, such as medical consultations, surgical procedures, examinations, testing and others, calculated since 2015.
The D-TISS database will be of the utmost importance to operationalize the Open Healthcare project, currently undergoing analysis by the ANS, given that it enables access and collaboration regarding information on supplementary healthcare. As a result, following the update of the system, data on the 2021 period are available for consultation, as well as new data on the 2019 and 2020 periods.
MAPA – Ministry Of Agriculture, Livestock and Food Supply
Family farming made the focus of MAPA project
MAPA instituted the “Brazil Mais Cooperativo” Program, aimed at contracting technical support services to qualify and stimulate family farming projects.
In October, a Public Call was opened for service providers to express their interest in participating. The project is expected to involve 162 providers, located throughout six Brazilian states, benefiting about 102 family farming projects.
The period for interested companies to submit proposals closed on November 09, 2022.
CFM – Brazilian Federal Council of Medicine
Negative repercussions of restrictions on Cannabis Products causes CFM to suspend the effectiveness of the rule
Ten days following the publication of Resolution 2,324/2022, which provides for prescription requirements for Cannabis Products, the CFM suspended its effectiveness.
Among the key aspects of the proposed wording are:
- Doctors are restricted to the prescription of cannabis exclusively for the treatment of epilepsy in young children and adolescents.
- Doctors are forbidden from giving lectures and courses on the subject outside the scientific environment.
- The Rule remains unclear as to provisions for THC (tetrahydrocannabidiol), which is a substance allowed by ANVISA up to a limit of 0.2%.
In view of the identified repercussions, the CFM opened a public consultation to receive contributions on the topic until December 23, 2022. It is worth mentioning that RDC 327/2019 of ANVISA is being revised and is expected to undergo changes, including considerations resulting from the impact of the new regulation of CFM, still suspended.
[/vc_column_text][vc_empty_space height=”40px”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]LEGISLATION
COFEN – Federal Nursing Council
Bill proposes a source of funds for financing the nursing wage floor
In October, the Federal Senate approved Complementary Bill No. 44, of 2022 (“PL”), which provides for the source of funds for financing the nursing wage floor (Law No. 14,434/2022).
The Bill will be revised and voted on by the House of Representatives.
The proposal establishes permission for the use of funds from state and municipal health and social assistance sources. Such permission will allow the allocation of public funds for the nursing wage floor.
The Federal Senate proposed the PL as a temporary costing measure in response to the Supreme Court’s suspension of the effectiveness of the nursing wage floor law due to insufficient public funds.
ANVISA – Brazilian National Health Regulatory Agency
New and innovative medicines are now governed by a new regulatory framework
On October 05, 2022, ANVISA published RDC No. 753/2022 and IN No. 184/2022, which provide for the registration of medicinal products for human use classified as new, innovative, generic and similar. The new Rules entered into force on November 01, 2022.
Instead of following the general legislation, the new Rules regulate the registration of medicines under these specific classifications, in order to encourage the development and production of these medicines, as well as to offer to the market new alternatives for the treatment of diseases.
In addition to a simplified method of registration, the inclusion of technical data analyzed by international health entities, such as accounts, reports or technical opinions, is also allowed.
ANVISA – Brazilian National Health Regulatory Agency
ANVISA encourages health oversight educational initiatives
On October 25, 2022, ANVISA published Rule No. 968/2022, which establishes the parameters of the “AnvisaEduca” project, whose aim is to implement educational initiatives on health oversight in the basic public education network.
The project’s guidelines are based on fostering social development, consistent monitoring and evaluation, appropriate communication to the general public and facilitating the use of didactic teaching resources. ANVISA’s advisors will be in charge of carrying out the project.
ANS – Brazilian Supplementary Healthcare Agency
Rules applicable to the Regulatory Impact Analysis and Social Participation procedures defined
On October 17, 2022, NR No. 548/2022 was published, introducing a new definition on procedures applicable to the Regulatory Impact Analysis (“RIA”) and Social Participation (“PS”) procedures, and repeals Resolution No. 242/2010, as well as provisions of Resolution No. 49/2012.
The PS process encompasses methods to gather contributions from the general public (through public consultations, public hearings or public calls for contributions ), while the RIA is a systematic process of analysis that seeks to evaluate a regulatory problem and its expected effects, as well as identify possible measures that can be adopted to achieve the desired result, in order to assist in decision-making regarding supplementary healthcare.
MS – Brazilian Ministry of Health
Private companies allowed to purchase Covid-19 vaccines
On October 25, 2022, the Federal Senate approved Provisional Measure (“MP”) No. 1,126/2022, which provides for the acquisition and distribution of Covid-19 vaccines by private legal entities.
The text is still pending enactment and publication.
The MP repeals Law No. 14,125/2021, which established the obligation of private companies to donate 50% of the vaccines they acquired during the Covid-19 pandemic to the Brazilian Unified Health System (SUS), after the immunization of priority groups, and that companies needed to provide detailed information to the Ministry of Health about the acquisition and application of vaccines.
As a result, companies in the health sector will be allowed to purchase Covid-19 vaccines without any restrictions on donations or reporting.
MS – Brazilian Ministry of Health
Popular Pharmacy Program has updated rules
On September 30, 2022, Rule No. 3,677 of 2022, which provides for the coverage expansion of the Brazilian Popular Pharmacy Program (PFPB) and for new rules on dispensing medicines and inputs.
The expansion of the list of free medicines encompasses the treatment of hypertension, diabetes mellitus, and asthma. In addition, medicines and geriatric diapers were also covered by the extension (in the co-payment modality), for contraception, dyslipidemia, rhinitis, Parkinson’s disease, osteoporosis, glaucoma, incontinence, and diabetes mellitus associated with cardiovascular disease.
In order to request such dispensing, an official photo identification document, and prescription must be presented within the period of validity and the requester must be 60 years old or older, in case of request for geriatric diapers.
MAPA – Ministry of Agriculture, Livestock and Food Supply
Rule establishes parameters for the registration of cultivars
On October 20, 2022, Rule No. 502/2022 was published, establishing the rules for the registration of cultivars and species in the National Registry of Cultivars (RNC), aiming to establish greater clarity regarding activities carried out by professionals in the field. The Rule came into force on November 01, 2022.
Among the main changes are:
- cases in which the registration of materials is waived;
- 15-year registration period, extendable for as long as the activity is carried out; and
- requirements and obligations of the maintainer.
MAPA – Ministry of Agriculture, Livestock and Food Supply
Technical regulation establishes parameters for the production of ground beef
On October 03, 2022, Rule No. 664/2022 was published, providing for the technical regulation of identification and quality of ground beef, aiming to modernize production and industrial procedures in order to ensure the biological safety of the product.
Among the main rules, we highlight that:
- The raw material must consist exclusively of meat, and the use of industrial meat is prohibited.
- Each package must comply with the weight limit of one kilogram; and
- the labels must contain words prohibiting retail sale, as well as prohibition of profit splitting on the product.
The rules apply to meat packing plants that produce ground beef registered with MAPA’s Federal Inspection Service, which will have one year to adapt their production in accordance with the new rules.
MAPA – Ministry of Agriculture, Livestock and Food Supply
Working Group created to analyze public policies for women that work in rural areas
On October 19, 2022, Rule No. 500/2022 was published, providing for the establishment of a Working Group to analyze the implementation of the Brazilian Observatory for Women in Agriculture.
The project, which is an initiative from MAPA, aims to help structure the database and information relevant to women in agriculture, in order to enable the development and implementation of public policies aimed at women working in rural areas.
The Working Group will be composed of women from various MAPA bodies, such as the Secretariat for Agricultural Defense, Family Farming and Agricultural Policy.[/vc_column_text][vc_empty_space height=”40px”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]PUBLIC CONSULTATIONS AND HEARINGS:
ANS – Brazilian Supplemental Healthcare Agency
Public Consultation to obtain suggestions for changes in the ANS’ list of mandatory procedures is concluded
On October 03, 2022, the ANS opened for public consultation a Draft Resolution that aims to update the list of mandatory procedures and events for health plan operators, established in Law No. 9,656/1998.
The matter had already been discussed at the 9th Technical Meeting of the Commission for Updating the List of Procedures and Events in Supplementary Healthcare (COSAÚDE).
The new Resolution introduced changes to Resolution No. 465/2021 and provides for mandatory coverage for procedures of “Intravenous, Intramuscular or Subcutaneous Immunobiological Therapy” as well as for the drug “Certolizumab Pegol”, used to treat psoriasis in patients with moderate to severe plaques and for whom conventional therapy has failed, shows intolerance or has been contraindicated, as well as to candidates for systemic therapy.
The public consultation, which included several studies and technical reports, was concluded on October 24, 2022, and the final version of the text, containing the new mandatory procedures to be included in the ANS’ list, will soon be published.
Anvisa – Brazilian National Health Regulatory Agency
Simplification of precautionary rules applicable to healthcare plan operators is subject to public hearing
On September 29, 2022, during public hearing No. 25 of the Board of Standards and Operator Qualification (“DIOPE”), a proposal was presented to simplify precautionary regulations.
The proposal aims in particular to terminate the solvency margin in cases of bankruptcy of healthcare plan operators and to adopt Risk-Based Capital (CBR), measures that were expected to be implemented only in 2023.
According to DIOPE, the relaxation of these rules will bring more autonomy to operators that already fall within the regulation concerning regulatory capital, reduction in regulatory costs, efficiency gains, better adjustment to the risk incurred, and debureaucratization of the regulatory framework.
MS – Brazilian Ministry of Health
Working Group discuss regulation of medical schools in Brazil
On October 20, 2022, the discussions about the regulation of medical schools in Brazil were concluded, carried out by a Working Group composed of members from the Ministry of Health, Ministry of Education, Federal Council of Medicine, and private associations.
The contributions were mainly based on the following topics:
(i) Current landscape of medical education in Brazil
(ii) Geographic distribution of graduates
(iii) Quality assessment of teaching and faculty for undergraduate courses in medicine
(iv) Teaching hospitals
(v) Association with medical residency programs
The discussion will be helpful to the Federal Government in developing public policies for healthcare and medical teaching, as well as the suitability of medical school regulations. There is still no schedule for publication of new regulations.
MAPA – Ministry of Agriculture, Livestock and Food Supply
Pest control in citrus cultivation is subject of public consultation
The National Program for the Prevention and Control of citrus disease is the subject of the public consultation carried out by MAPA. Interested parties can submit their contributions within 60 days.
The disease is known as “citrus greening” and currently represents the greatest threat to citrus cultivation worldwide. The public consultation aims to improve the tools to control the pest and establish production criteria in rural establishments.
MAPA – Ministry of Agriculture, Livestock and Food Supply
Public consultation analyzes proposals on environmental regularization
During the month of October, contributions on the RegularizAgro project were received. The project was established by Decree No. 11,015/2022, which establishes the National Plan for Environmental Regularization of Rural Real Estate.
The proposal aims to regularize such real estate and implement the mechanisms provided for in the Forest Code. Therefore, a Management Committee has been created within MAPA, which will develop strategies and actively contribute to the success of public and public-private initiatives.[/vc_column_text][vc_empty_space height=”40px”][/vc_column][/vc_row]
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