Life Sciences Newsletter No 29

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

NEWS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

ANVISA issues first operation license for germ cells and embryos importer

On October 30, 2023, ANVISA granted the first authorization for an importing company of germ cells, germ layers and human embryos to import, transport, store and distribute cells, germ layers, and embryos for assisted human reproduction.

At the end of 2022, Collegiate Board Resolution (“RDC”) RDC 771/2022 had changed import rules and good practices regarding germ cells, germ layers, and human embryos. As a result, importing companies are now required to have a certification that must be renewed every two years.

The contributions were accepted by Anvisa until November 24, 2023 and must be published soon.

MS – MINISTRY OF HEALTH AND MEC – MINISTRY OF EDUCATION

Notice regarding authorization for new medical courses published

On October 04, 2023, Public Call Notice No. 1 was published to obtain authorizations for new medical courses in Brazil.

This public call comes within the context of the Mais Médicos Program, reinstated by Law No. 12,871/2013.

The notice provides for up to 95 new medical courses in Brazil, which can be offered in pre-selected cities, provided that there is only one course per health region. In addition, proposals aimed at cities with a lower number of attending physicians will receive more subsidies to stimulate health practitioners to work in such areas.

MS – BRAZILIAN MINISTRY OF HEALTH

Plasma PEC approved by the Brazilian Federal Senate

On October 04, 2023, the Committee on Constitution and Justice and Citizenship (“CCJ”) of the Brazilian Federal Senate approved Proposed Amendment to the Constitution (“PEC”) No. 10/2022, thus amending Article 199 of the Federal Constitution to provide for conditions and requirements involving the collection and processing of human plasma.

The main change introduced by this PEC is the authorization to trade plasma, which is currently forbidden, as it falls under the ban on the sale of human tissues. In addition, plasma processing by the private sector has been authorized for the production of blood products, preferably allocated to the Brazilian Unified Health System (“SUS”). Currently, the sole company responsible for plasma processing in Brazil is Hemobrás (Brazilian Company of Blood Products and Biotechnology).

The proposal must still be analyzed by the Senate and, if approved, will move forward to the Brazilian House of Representatives.

Bill proposes authorized use and trade of e-cigarettes

On October 17, 2023, the Bill No. 5,008/2023 was published to provide for the production, import, export, trade, control, monitoring and advertising of electronic cigarettes, in addition to other measures.

Any activities relating to e-cigarettes have been banned by ANVISA since 2009. To regularize this product, the bill establishes that e-cigarettes must be registered with ANVISA and that competent authorities must monitor the production and sale of such products to avoid irregular imports.

MAPA – MINISTRY OF AGRICULTURE AND LIVESTOCK

Senate approves bill on the production of bioinputs for agriculture

On October 04, 2023, the Brazilian Federal Senate approved Bill No. 3,668/2021, which provides for the production, registration, trade and other activities relating to the production of bioinputs for agriculture, among other provisions.

The approved text includes requirements to the production of bioinputs for commercial and personal use, to obtain applicable licenses and registrations, and criteria for transporting products.

The bill in currently under analysis by the Brazilian House of Representatives.

LEGISLATIONS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

New deadline established regarding old food product labels

On October 09, 2023, ANVISA published RDC No. 819/2023, which amended RDC No. 429/2020 regarding deadlines for the stocking of food packaging and labels.

The new regulation took into consideration the effects of the Covid-19 pandemic on the supply chain.

In this regard, the deadline for emptying stocks of packaging and labels purchased until October 8, 2023, ends on October 9, 2024. Companies that do not adjust within the deadline may be fined by the municipal and state health oversight departments.

ANVISA publishes list of impurity limits in pharmaceutical products

On October 17, 2023, RDC No. 821/2023 and Normative Instruction No. 258/2023 were published, which:

• provide for the list and limits of qualified impurities in pharmaceutical products; and
• amend RDC No. 53/2015which establishes parameters for notification, identification and qualification of degradation products in synthetic and semi-synthetic active ingredients.

Currently, RDC 53/2015 already provides for criteria to define qualified impurities, which are when the compound:

• is a metabolite;
• has been described in scientific literature or official list; and
• has been evaluated through toxicity studies.

Under the criteria established by RDC No. 53/2015, several degradation products/impurities had been flagged repeatedly in administrative processes of registration or post-registration of active pharmaceutical ingredients. As such, ANVISA decided to establish a list that qualifies the most recurrent impurities to avoid unnecessary repetition of qualification processes.

ANVISA amends regulations on clinical laboratories

On October 27, 2023, RDC No. 824/2023 was published, to amend RDC No. 786/2023, which establishes the technical-health requirements for the operation of laboratories that conduct clinical analyses.

The main amendments concern the analysis of biological materials, among which we highlight:

• Express appointment of the laboratory responsible for packaging and storing biological material in compliance with RDC No. 504/2021, which establishes good practices for the transport of biological material;
• Tertiary packaging of transported material must contain all information required by RDC No. 504/2021;
• Waiver from appointing a supporting laboratory outside Brazil in the National Register of Health Institutions.

In addition, RDC 824/2023 extended the application of technical and health requirements for laboratories to all public or private services that conduct clinical analyses, rather than only legal entities, as the previous regulation provided for.

ANVISA implements personal data protection policy

On October 19, 2023, Ordinance No. 1,184/2023 was published, implementing ANVISA’s personal data protection policy.

The new regulations apply procedures involving privacy, personal data protection, transparency, access to public information, and the protection of civil rights and liberties.

ANVISA has defined Fala.BR as the official channel for data subjects to submit requests to access their personal data. Finally, among the personal data protection measures are encryption, anonymization and protection against unauthorized access to Anvisa’s systems.

MS – BRAZILIAN MINISTRY OF HEALTH

Ministry of Health selects health projects for New GAP

On October 09, 2023, the Ministry of Health published Ordinance No. 1,517/2023, which establishes the selection process for health projects within the scope of the new Growth Acceleration Program (“New GAP”).

The selection process is aimed at federal entities interested in submitting proposals regarding Primary Health Care and Specialized Care within the health modalities of the new GAP. The proposals must focus on improving the local health infrastructure, including Primary Healthcare Units, maternity wards and hospitals, emergency centers, among others.

The health section of the New GAP will stimulate the growth and development of the health sector in Brazil, which creates expectation for partnerships with the private sector to execute these projects.

PUBLIC CONSULTATIONS AND HEARINGS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

ANVISA receives contributions on the registration of biosimilars through comparability studies

On October 11, 2023, ANVISA opened Public Consultation No. 1,206/2023 to receive contributions on a proposed resolution that:

• provides for the registration of biosimilars through development and comparability studies; and
• revokes Chapter V of RDC No. 55/2010, which currently provides for the procedure to register biological products through development and comparability studies.

Among the proposed amendments is the possibility of using a comparative biological medicine acquired on the international market in countries regulated by an Equivalent Foreign Regulatory Authority recognized by ANVISA, provided that the manufacturers of the active ingredient and the finished product have been verified to be the same as those of the medicine registered in Brazil.

The contributions were accepted by Anvisa until November 24, 2023 and must be published soon.

Public consultation analyzes proposed exemption from notifying post-registration changes to biological products

On October 11, 2023, Public Consultation No. 1,207/2023 was opened to receive contributions on the proposed amendment of Article 22 of RDC No. 413/2020, which provides for post-registration changes in biological products.

Currently, Article 22 states that companies must inform ANVISA of any simultaneous changes (on a moderate or higher level) to a product. The amendment proposes the exemption from notifying in ANVISA in cases where:

• There is one main change and further relating changes;
• The documentation of additional changes matches the documentation submitted for the main change; or
• The amendments fall under the same scope of Normative Instruction No. 65/2020 in regard to one converging technical rationale.

The contributions were accepted by Anvisa until November 24, 2023 and must be published soon.

ANVISA proposes extended validity for medical device manufacturers best practice certificates

On October 25, 2023, Public Consultation No. 1,208/2023 was opened to receive contributions on a proposed extension to the validity of Good Manufacturing Practices certificates granted through the Medical Device Single Audit Program (MDSAP) to medical device manufacturers.

Currently, RDC No. 497/2021 states that the certificate is effective for two years. The proposed resolution establishes the extension of this period to four years, exclusively for certification granted through the MDSAP to medical device manufacturers. This extension is subject to the manufacturer’s enrollment in the MDSAP throughout the entirety of the certificate’s effectiveness.

The MDASP is an international program that consolidates the audit process of health products, so that manufacturers can contact an authorized auditor enrolled in the program.

Contributions may be sent by December 08, 2023, through this online form.

Public consultation analyzes amendments to post-study programs for medicine access and supply

On October 27, 2023, Public Consultation No. 1,210/2023 was published, to analyze the proposed review of RDC No. 38/2013, which approved the regulation on programs involving post-study expanded access, compassionate use and supply of medicines.

The main proposed changes regard the optimization of the registration procedure for higher-risk cases, to ensure greater safety to patients and speed up the processing of requests to assistance programs.

Contributions can be submitted by January 02, 2024.

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

Proposed amendment to PEONA SUS subject to public consultation

Public Consultation No. 115 was concluded on October 13, 2023. The consultation received contributions on a proposed resolution to amend Normative Resolution No. 574/2023, which provides for criteria relating to technical provisions that must be followed by healthcare plan operators.

The proposed changes concern criteria related to technical provisions that must be followed by healthcare plan operators, particularly the Provision on Incurred but not Reported Losses to SUS (“PEONA SUS”). As such, the number of losses from the previous 24 months that must be reported (SUS procedures) decreased from 80% to 66% for operators that do not have their own actuarial methodology to calculate the PEONA.

Public consultation receives contributions regarding changes to DIOPS/ANS submission deadlines and parameters

On October 13, 2023, Public Consultation No. 116 was closed. The consultation received contributions on a proposed resolution amending Normative Resolution No. 527/2022, which provides for the XML version of the Brazilian Supplementary Health Agency’s Economic and Financial Information Report (“DIOPS/ANS”).

The main proposed changes concern the reduction of deadlines to submit quarterly DIOPS/ANS, as well as the implementation of the simplified monthly DIOPS-XML for the remaining months, and the criteria for mandatory reporting, to improve accessible ANS content.

Public consultation analyzes inclusion of cancer treatment drug in list of mandatory health events and procedures

On October 24, 2023, Public Consultation No. 118 was closed. The consultation received contributions regarding a proposed resolution to amend Normative Resolution No. 465/2021, which provides for the list of mandatory health procedures and events in supplementary health.

The proposal aims to include oral antineoplastic cancer treatment (procedure and medicines) in the list of mandatory procedures and health events.

MAPA – MINISTRY OF AGRICULTURE AND LIVESTOCK

MAPA opens public consultation on animal cell multiplication

On October 31, 2023, the MAPA opened a public consultation regarding a proposed ordinance that establishes procedures of registration, control and supervision of animal cell multiplication traders.

Currently, this multiplication procedure is regulated by Normative Instruction No. 56/2007, whose former provisions demanded updating in line with the current landscape of the industry. Among the proposed changes are:

• increased accuracy in each stage and requirement within the procedure to register traders;
• 60-day deadline to cancel registration after closure; and
• specific requirements on physical facilities.

Contributions may be sent by December 15, 2023, through this online form.