Life Sciences Newsletter | December 2023

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 legal team.

Enjoy reading! Demarest’s Life Sciences Team

NEWS

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

STJ decides that operators cannot cut back home care without medical approval

On December 14, 2023, on Special Appeal No. 2,096,898, the Third Panel of the Superior Court of Justice (“STJ”) unanimously decided to ban healthcare plans from cutting back on home care services without approval from a qualified physician.

The STJ argued that the sudden and significant reduction in healthcare during the treatment of a serious illness, and against medical recommendations, not only violates the principles of good faith, contractual social responsibility and human dignity, but also qualifies as abusive conduct by the healthcare plan. In addition, Justice Nancy Andreghi emphasized in her vote that interrupting of home care services without prior approval or recommendation for a qualified physician qualifies as poor service delivery and patients are entitled to damages for pain and suffering.

ANS establishes refund rules for operators and beneficiaries

On December 18, 2023, during the 599th Meeting of the ANS Collegiate Board (“DICOL”), the ANS approved a refund regulation on healthcare plan operators and beneficiaries.

Among the provisions of the document, the ANS clarified that policyholders are only entitled to a refund after they have paid for a given service. In addition, the ANS emphasized that the beneficiaries’ data – such as login and password – are personal, confidential, and non-transferable, and subject to the Brazilian General Data Protection Law (“LGPD”).

 The 59th DICOL Meeting agenda is available, but the approved regulation has yet to be published.

TJSP program facilitates negotiation between beneficiaries and healthcare plans

On November 16, 2023, the Court of Appeals of the State of São Paulo (“TJSP”) launched the “Health and Mediation Program” (“Programa Conciliando com a Saúde”, in Portuguese), aimed at encouraging out-of-court agreements (“self-mediation”) in disputes involving healthcare plan operators and beneficiaries, thus improving negotiation between these parties and reducing the judicial caseload in the state.

Both operators and consumers can attempt to reach an agreement through the program, whether before or during the processing of the case. To join the program, applicants must submit an electronic form available on the TJSP website, which will move forward to the competent Judicial Center for Dispute Settlement and Citizenship (CEJUSC). Subsequently, the parties will attend a virtual mediation session and, if should they reach an agreement, it will be ratified by the judge and effective as a judicial decision.

More than 43 operators have already joined the TJSP program, whose launch involved the collaboration between the ANS and consumer protection authorities such as the Brazilian Consumer Protection Office (PROCON) and the Public Prosecution Office, in addition to the Department of Justice and Citizenship of the Government of São Paulo.

MS – BRAZILIAN MINISTRY OF HEALTH

STF recognizes law on the disclosure of medicine stocks in public pharmacies as constitutional

On November 29, 2023, the Brazilian Federal Supreme Court (“STF”) published its decision that recognized the constitutionality of São José do Rio Preto’s Municipal Law No. 14,120/2022, which seeks to expand the population’s access to information by requiring that data regarding medicine supply and stock in public pharmacies be publicized.

This decision concludes a direct action for declaration of unconstitutionality filed against the municipal law, due to allegedly violating the separation of powers principle. Although the TJSP had partially granted the action, the Public Prosecution Office of the state of São Paulo filed an extraordinary appeal before the STF, which was granted.

As a result, the list of available medicines in municipal public pharmacies must be updated daily, while names and quantity of each medicine must be updated monthly.

Check here the judgment in full.                                                                                                 

MAPA – MINISTRY OF AGRICULTURE AND LIVESTOCK

Brazil granted pre-listing status for animal protein exportation to Singapore

Brazil has been approved by Singapore’s Health Sciences Authority in the pre-listing category for beef, pork, ovine and chicken exports, as well as their respective processed products.

As a result, MAPA will oversee the accrediting of meat packing plants to export these animal proteins to Singapore. In this regard, Brazil’s and MAPA’s autonomy has increased in terms of animal protein export relationships with Singapore, rendering MAPA’s decisions as equally effective to Singapore’s health oversight authority when it comes to animal protein products.

Given that in 2022 alone, Brazil exported nearly USD 600 million in meat and derived products to Singapore, this upgrade is undeniably significant for the country.

LEGISLATIONS

STATE AUTHORITIES

State of São Paulo finally regulates law that approved the supply of Cannabis-derived medicines by SUS

After nearly a year, on December 26, 2023, State Decree No. 68,233/2023 was published to regulate State Law No. 17,618/2023.

This law implemented the state policy on the free supply of medicines produced from cannabidiol plant-based medicines associated with other cannabinoid substances, such as tetrahydrocannabinol, to be enforced as an exception by the Executive Branch in public and private health facilities in the state of São Paulo within the Brazilian Unified Health System (“SUS”).

Unlike the state law, which provided for the supply of medicines derived from the base of cannabidiol, the new decree takes the large number of Cannabis products currently registered with ANVISA and expands the scope of the policy, providing for the supply of cannabidiol-based products.

Finally, the decree also establishes that the Health Department of the state of São Paulo will oversee the dispensing of cannabis-based products and medicines.

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

Regulation on in vitro diagnostics devices updated

On December 11, 2023, Collegiate Board Resolution (“RDC”) No. 830/2023 was published to update the regulation on risk classification, notification and registration schemes, and on the labeling and instructions of use requirements for in vitro diagnostics medical devices, as well as their instruments.

In addition, the new RDC repeals RDC No. 36/2015 and other related regulations.

Among the main changes, the new RDC establishes new parameters for the classification of risks involved in the use of in vitro diagnostics devices.

Companies must adjust to the new regulations by June 01, 2024.

Advanced therapy product regulations updated

On December 18, 2023, two important regulations were published to provide for good practices in the production of advanced therapy products:

• Normative Instruction No. 270/2023, which establishes the rules of good manufacturing practices complementary to advanced therapy medicinal products; and
• RDC No. 836/2023, which updates good practices in therapeutic use of and clinical trials with human cells, in addition to repealing RDC No. 508/2021.

These innovations aim to update the procedure to regulate advanced therapy medicinal products in line with the current demands of the sector, as well as establish more certainty within Brazil’s regulatory landscape and attract more advanced therapies, given that only five products of this category have been approved in the country.

As a result, the regulatory framework for advanced therapies is now formed by these two new regulations, together with RDC No. 685/2022, which provides for best practices in medicine production.

Health warnings updated for tobacco-related products

On December 18, 2023, four new regulations were published regarding tobacco-derived products:

• RDC No. 838/2023, which provides for the packaging of tobacco-derived products;
• Normative Instruction No. 271/2023, which provides for health warnings that must be printed in the packaging of tobacco-derived products, under the terms of RDC No. 838/2023;
• DRC No 840/2023, which lays down the exposure for sale and marketing of tobacco-derived products and repealing DRC No 558/2021; and
• Normative Instruction No. 272/2023, which provides for health warnings that must be used in point of purchase displays of tobacco-derived products, under the terms of RDC No. 840/2023;

These innovations concern health warnings on the packaging of tobacco-derived products: While the current regulation will remain in force until November 02, 2025, new parameters are expected to be published by November 01, 2024. This change is aimed at ensuring more certainty regarding upcoming amendments to the regulation.

In addition, the changes include a required warning “CAUTION: TOXIC PRODUCT” and a description of each substance’s potential harm to health.

Regulations updated on clinical trials involving medical devices

On December 15, 2023, RDC No. 837/2023 was published, which provides for clinical trials involving medical devices in Brazil, as well as repealing RDC No. 548/2021.

Among the main amendments are the adoption of a simplified authorization procedure for class I or II clinical trials, as well as the establishment of applicable sanctions in these cases, to meet the current health safety demands within the scope of these devices.

The amendments resulted from a previous administrative proceeding that was subject to Public Consultation No. 1.123/2022, which received 125 contributions.

Regulatory framework for new foods and ingredients updated

On December 18, 2023, RDC No. 839/2023 was published to update the regulatory framework for safety certificates and authorization of new foods and ingredients.

Among the main innovations are:

• Possibility to verify with ANVISA whether a certain food or ingredient is actually new;
• Procedure to update the list of approved substances in food production;
• List of required information for the analysis of new foods and ingredients’ registration applications.

These changes were the result of a previous administrative proceeding involving Public Consultation No. 1,158, which received 1,236 contributions on the subject, further evidencing the importance of the topic.

The new resolution will enter into force on March 16, 2024, except for Articles 7, 8 and 9, which provide for the disclosing of ANVISA’ decisions on applications.

ANVISA updates list of approved food additives and co-formulants

On December 12, 2023, Normative Instruction No. 267/2023 was published to amend Normative Instruction No. 211/2023, which provides for the technological functions, limits and conditions of use for authorized food additives and processing co-formulants.

The changes in the list include:

• Exclusions, changes and inclusions in the list of authorized food additives and their respective technological functions, limits and conditions of use (Annex III to Normative Instruction No. 211/2023).
• Exclusions, changes and inclusions in the list of authorized food processing co-formulants and their respective technological functions, limits and conditions of use (Annex IV to Normative Instruction No. 211/2023).

The new regulation entered into force on January 01, 2024.

Regulations on medicine package inserts updates

On December 11, 2023, RDC No. 831/2023 was published, amending RDC No. 47/2009, which provides for the development, standardization, update, publication and supply of medicine package inserts for patients and healthcare professionals.

The main innovations concern package inserts for reference medicines that are patented, thus establishing new instructions for reference medicines whose original patent has already expired (second medical use patents).

As a result, generic medicine package inserts can now be different from the patented medicines’ inserts in terms of instructions that have been patent protected or included in patent applications.

The resolution will enter into force on February 06, 2024.

Health requirements on vegetable oils and fats updated

On December 06, 2023, RDC No. 829/2023 as published , amending RDC No. 481/2023, which provides for health requirements on vegetable oils and fats.

The new RDC was published to fix gaps and inconsistencies in RDC No. 481/2021, and updates the following topics:

• Differentiated definition between virgin oils (RDC No. 481/2021) and virgin olive oils (MAPA Normative Instruction No. 01/2012);
• The definition of oil and fat blends no longer encompasses mixtures of oils and fats from different parts of the same plant species;
• Classification and nomenclature of vegetable oil and fat mixtures that contain at least one modified oil or fat;
• Information on fat blends and modified fats intended exclusively for industrial processing or food services listed on the labels.

Regulations on personal hygiene products, cosmetics and perfumes updated

On December 19, 2023, RDC No. 841/2023 as published , amending RDC No. 752/2023, which provides for health requirements on personal hygiene products, cosmetics and perfumes.

The amendments include the possibility of adopting the simplified procedure listed in RDC No 772/2022 or amending labels in the following cases:

• Updating the label art for the sole purpose of adjusting mandatory information to small-sized primary packages, under the terms of Articles 15 and 16 of RDC No 752/2022;
• Updating warnings and use restrictions on label, pursuant to Article 24 of DRC No 752/2022.

Requests for modify labels of personal hygiene products, cosmetics and perfumes must be submitted by October 03, 2025.

ANVISA approves 2024/2025 regulatory agenda

On December 18, 2022, Ordinance No. 1,409/2023 was published , establishing ANVISA’s 2024-2025 Regulatory Agenda.

Among the main topics of the agenda are:

• Review of the list of approved additives for production of plastic materials and polymer coatings used in contact with food, seeking to enable safe access to products and services that are essential to the population’s health;
• Good practices in pharmacies and drugstores;
• Requirements for granting and amending operation authorizations of compound pharmacies, and review of documentation for applications to obtain such authorizations.
• Customization and requirements for regularization of organic cosmetics;
• Admissibility of foreign pharmacopeias as a reference in the quality control of inputs and pharmaceutical products and in the implementation of good pharmaceutical practices within the Brazilian Pharmacopoeia;
• Development of a legal framework for post-registration changes of advanced therapy medicinal products;
• Regulation on medical device-related innovations.

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

List of mandatory procedures and events in supplementary health updated

In December 2023, the ANS published two normative resolutions to update the list of mandatory health procedures and events in supplementary health:

• On December 08, 2023, Normative Resolution 591/2023 was published to amend Normative Resolution 465/2021, which provides for:
  • pomalidomide (oral antineoplastic medicine), in combination with bortezomib and dexamethasone, for the treatment of patients with refractory and relapsed multiple myeloma, after at least one previous therapy including lenalidomide; and
  • ustekinumab (immunobiological medicine) for the treatment of adult patients with moderate to severe ulcerative colitis (UC) after failure, refractoriness, relapse or intolerance to treatment with tumor necrosis factor in inhibitors (TNF inhibitors).
• On December 08, 2023, Normative Resolution 592/2023 was published to amend Normative Resolution 465/2021, which provides for:
  • Emicizumab, for prophylactic treatment of patients with moderate to severe hemophilia A and factor VIII inhibitors, without age restriction; and
  • Zoledronic acid, for the treatment of patients with osteoporosis who suffer from difficulty or intolerance related to the oral intake of bisphosphonates.

Accordingly, Annex II to Normative Resolution No. 465/2021 will enter into force together with the instructions of use for the medicines above.

ANS regulates nonpayment notification to private and collective healthcare plan beneficiaries

On December 19, 2023, Normative Resolution No. 593/2023 was published, providing for nonpayment-related notification to:

• Individuals contracting a private healthcare plan; and
• Beneficiaries that directly pay the operator every month for a collective healthcare plan.

This resolution will regulate:

• Mandatory notification due to nonpayment;
• Means to carry out such notification; and
• The content of the notification, which only applies to contracts entered into after January 01, 1999, or adjusted in line with Law No. 9,656/1998.

In addition, the resolution meets the notification requirement established in the sole paragraph, II, Article 13 of Law 9,656/1998, in addition to being applicable, as appropriate, to all other notifications and communications to the beneficiary or to the contractor, even in other cases.

Finally, the resolution repeals Precedent No. 28/2015, which provided for the required content of notifications submitted by healthcare plan operators, and will enter into force on April 01, 2024.

Resolution establishes 30-day deadline to provide contraception methods and techniques

On December 19, 2023, Normative Resolution No. 595/2023 was published to provide for amendments to the guarantee of care for beneficiaries of private healthcare plans, as well as to regulate a provision of paragraph 2, Article 9, of Law No. 9,263/1996, included by Law No. 14,443/2022.

Article 9 provides for the right to family planning, requiring that healthcare plans provide all conception and contraception methods and techniques that are scientifically accepted and that do not jeopardize the life and health of the beneficiaries, observing their right to choose. In this regard, paragraph 2 established a maximum 30-day period for the supply of any contraception method and technique.

As such, the resolution amends Normative Resolution No. 566/2022, including in Article 3 the obligation to comply with the 30-day period mentioned above. The new wording entered into force on January 01, 2024.

MS – BRAZILIAN MINISTRY OF HEALTH

Ministry of Health announces regulatory framework for the National Strategy for Development of the Health Economic-Industrial Complex

In December 2023, the Ministry of Health published the regulations that make up the regulatory framework for strengthening the National Strategy for the Development of the Health Economic-Industrial Complex in Brazil, established by Decree No. 11,715/2023.

The following regulations have been published:

• GM/MS Ordinance 2,259/2023: Establishes the Production and Technological Development Program for Neglected Populations and Diseases;
• GM/MS Ordinance No. 2,260/2023: Establishes the Program for Preparation of Vaccines, Fluids and Blood Derivatives (“PPVACSH”);
• GM/MS Ordinance 2,261/2023: Establishes the Matrix of Productive and Technological Challenges in Healthcare;
• GM/MS Ordinance 2.262/2023: Establishes the Program for the Infrastructure Expansion and Modernization of the Health Economic-Industrial Complex.

In addition, public consultations No. 53/2023 and No. 54/2023 were opened to receive contributions on Partnership Program for Local Development and Innovation (“PDIL”) and the Partnership Program for Productive Development (“PDP”).

Contributions can be submitted by February 08, 2024.

MAPA – MINISTRY OF AGRICULTURE AND LIVESTOCK

Decree establishes the National Program for the Conversion of Degraded Pastures into Sustainable Agricultural and Forestry Production Systems

On December 05, 2023, Decree No. 11,815/2023 was published  which establishes the National Program for the Conversion of Degraded Pastures into Sustainable Agricultural and Forestry Production Systems (PNCPD), to foster public policies aimed at recovering degraded lands through good agricultural practices that lead to a higher level of carbon capture than that of degraded pastures.

The Brazilian National Bank for Economic and Social Development (BNDES) will be responsible for assisting MAPA in the external fundraising. In addition, the program will be aimed exclusively at producers enrolled in the Rural Environmental Registry.

PUBLIC CONSULTATIONS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

Proposed regulation on electronic package inserts subject to public consultation

On December 13, ANVISA opened Public Consultation No. 1,224 to receive contributions on a proposed regulation on the offering of electronic medicine package inserts.

The public consultation aims to reduce the percentage of printed package inserts and to provide for access to electronic package inserts through a label mechanism, as well as adjust the current regulation to Law No. 14,338/2022, which implemented the electronic package insert for medicines.

The public consultation will receive contributions until March 19, 2024, through this form.

Proposed regulation on the ban against electronic smoking devices subject to public consultation

On December 05, 2023, ANVISA opened Public Consultation No. 1,222 to receive contributions on a proposed regulation that bans the production, importation, sale, distribution, storing, transport and advertising of electronic smoking devices, such as e-cigarettes and vaping devices.

Although currently electronic smoking devices are already illegal, only RDC No. 46/2009 has provide for this matter.

The public consultation will receive contributions until February 10, 2024, through this form.

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

ANS opens public call for contributions on lines of care

On December 04, 2023, the ANS opened a public call for contributions on the priority lines of care in supplementary health, addressing care flow, clinical protocols, therapeutic guidelines and health indicators.

This initiative aims to collaborate with society to restructure healthcare services and increase the quality of care in the supplementary health sector. The public call targets operators, healthcare providers, and health experts’ societies and associations.

Contributions can be submitted by February 29, 2024 and will be analyzed by a selection committee formed by the teams in charge of healthcare quality assurance programs by the Sectoral Development Board.

Penalties against violations to private healthcare plan regulations subject to public consultation

On December 20, 2023, ANS published Public Consultation No. 124 to receive contributions regarding the proposed amendment to Normative Resolution No. 489/2022, which provides for the enforcement of penalties due to violations against the private healthcare plan legislation.

The public consultation will remain open for contributions until February 16, 2024 through this form.

MAPA – MINISTRY OF AGRICULTURE AND LIVESTOCK

Public consultation addresses a proposed regulation on procedures for reworking, revalidating and reprocessing formulated and technical products, and pesticide pre-mixes

On December 04, 2023, a public consultation was opened through Ordinance No. 961/2023 to receive contributions on a proposed joint ordinance by MAPA, IBAMA and ANVISA.

The goal is to establish guidelines for procedures of rework, revalidation and reprocessing of formulated products, technical products and agricultural pesticide pre-mixes, pursuant to Decree No. 10,833/2021.

The public consultation will remain open for contributions until January 20, 2024 through this form.