Life Sciences Newsletter No 30

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 technical note to confirm illegality of injectable aesthetic products

On November 13, 2023, Anvisa published Technical Note No. 33/2023, which explains the illegality of including injectable aesthetic products within the category of cosmetics.

Anvisa clarifies that these products cannot be regulated as cosmetics and warns consumers regarding the high health risks brought by these injectables. The technical note also provides for the proper labeling and use instructions of these products, to prevent serious damage to health.

Decision waives clinical trials to justify prohibition of medicines by Anvisa

On October 24, 2023, the 11th Panel of the Federal Regional Court of the 1st Region (“TRF1”) decided to confirm the understanding that the Ministry of Health is entitled to requiring the modification of medicines that are supposedly not suitable for human consumption, regardless of whether or not clinical trials on the matter have been published on indexed journals.

As such, Anvisa must only provide grounds for suspicions, which means producers are responsible for proving that the product is effective and does not offer health risks to consumers.

MS – BRAZILIAN MINISTRY OF HEALTH

Judicial decision authorizes supply of cannabidiol-based medicine to treat autism spectrum disorder

In November 2023, the 1st Federal Court of Guarapuava, in the state of Paraná, decided that the government must provide cannabidiol-based treatment for a three-year-old girl with autism spectrum disorder (“ASD”).

Although the medicine is not yet supplied by the Brazilian Unified Health System (“SUS”) and not registered with Anvisa, its potential to manage the patient’s symptoms can contribute to her social communication and reduce aggressiveness.

As such, due to the proven inability of the plaintiff to pay for this treatment, the government was assigned the responsibility of funding the medicine, while the Municipal Health Department of Palmas, in the state of Paraná, must communicate the plaintiff that the medicine is available, as well as deliver it and dispense/apply it.

Senate approves bill that establishes guidelines to cancer treatment

On November 22, 2023, the Committee on Social Affairs of the Federal Senate passed Bill No. 2,952/2022, which provides for the Brazilian Cancer Prevention and Management within the scope of the Brazilian Unified Health System (“SUS”), introducing guidelines to the provision of multidisciplinary healthcare for cancer prevention, treatment, rehabilitation and palliative care.  The goal is to reduce the incidence and mortality of the disease, and ensure patients’ access to comprehensive care, consequently contributing to improving their quality of life. In addition, this policy will allow for earlier diagnoses, which increases chances of curative treatment.

Finally, the new law also provides for the implementation of the Brazilian Program for Suspected or Diagnosed Cancer Patient Navigation, aimed at monitoring and supporting SUS cancer patients.

CNJ approves resolution to assist justices in public health decisions

In the second week of November 2023, the Brazilian National Council of Justice (“CNJ”) approved a resolution, which has not yet been published, aimed at assisting justices in public health cases.

 The proposal pertains to Subject Matter No. 84 of the Superior Court of Justice (“STJ”), which established that the judge is responsible for providing effective measures to enforce their decisions regarding medicine supply.

The new resolution is of paramount importance, as it will reduce judicialization on this matter, given that according to the Brazilian Office of the Comptroller-General, BRL 3.7 billion were spent to acquire medicines due to judicial decisions.

Bill that regulates clinical trials on humans approved by the House of Representatives

On November 29, 2023, the Brazilian House of Representatives passed Bill No. 7082/2017, which provides for clinical trials on humans.

The new law has the potential to be a regulatory landmark for clinical trials, as it establishes rights for voluntary trial participants, as well as duties for researchers, sponsors and other entities involved in the process, who must comply with ethical and scientific requirements throughout the process.

We highlight that setting deadlines to analyze research protocols for the issuance of technical opinions, together with the requirement for scientific justification and a description approved by the Research Ethics Committee, will ensure more credibility and legal certainty to the matter.

After approval by the House of Representatives, the bill will move forward to the Brazilian Federal Senate.

MAPA – MINISTRY OF AGRICULTURE AND LIVESTOCK

National program for conversion of degraded pastures under development

MAPA assisted the Brazilian Federal Government in drafting Decree No. 11,815/2023 establishing the National Program for the Conversion of Degraded Pastures into Sustainable Agricultural and Forestry Production Systems and its Inter-ministerial Management Committee.

The decree will serve as a guideline to the structuring of the program by the management committee, which will be formed by seven ministries and additional public entities.

The management committee aims to collect around USD 120 billion from Brazilian and international investors for the conversion of pastures in Brazil, particularly through the implementation of lines of credit.

LEGISLATIONS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

New regulation amends ethylene oxide limits in food additives

On November 27, 2023, Collegiate Board Resolution No. 826/2023 was published , amending Collegiate Board Resolution No. 778/2023, which provides for the use of food additives and co-formulants in foods.

The amendment concerns the limits for the use of ethylene oxide in food additives in order to adapt such parameters to the European standard for food additives.

List of low-risk medicines updated

On November 24, 2023, Normative Instruction No. 265/2023 was published , amending Normative Instruction No. 106/2021, which establishes the list of low-risk medicines subject to notification.

The main changes concern requirements on:

• ethanol;
• paracetamol and its derivatives; and
• simethicone.

According to Anvisa’s Collegiate Board, these changes aim to improve the regulating procedures for these medicines, taking into consideration the information available on these substances.  

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

Public consultation analyzes regulatory changes for investments to cover technical provisions

On November 30, 2023, Public Consultation No. 120 was opened to receive contributions on the proposed amendment to Normative Resolution No. 521/2022.

The new regulation provides for the allowance, registration, binding, custody, transfer and the limits of allocation and concentration for the investment of guarantees by operators within the supplementary health system.

In turn, the proposed amendment aims to eliminate the obligation to create guarantees to secure the amounts calculated for Insufficient Premium Provisions. The goal is to reduce regularization requirements and make the process more efficient, in addition to ensuring equal treatment for requirements on assets aimed at covering technical provisions relating to risks not incurred.

MS – BRAZILIAN MINISTRY OF HEALTH

Ministry of Health establishes notification model for administered immunobiological registration

On November 30, 2023, SAES/SVSA/SEIDIGI Joint Ordinance No. 25/2023 was published to establish the notification model for administered immunobiological registration.

In order to standardize the sharing of data within the scope of the Ministry of Health, the ordinance establishes criteria for the registration of administered immunobiological products, requiring that such data be provided by health operators for the establishment of a National Health Data Network. This database will be used to improve the quality of health care services.

Ordinance establishes criteria for national telehealth registry

On November 30, 2023, Ordinance No. 1.022/2023 was published, which amends the criteria on the registration of digital health, innovation and telehealth service providers in the National Register of Healthcare Establishments.

As such, given that telehealth services are still a recent topic for the Ministry of Health, specific registration criteria were established for these facilities. The changes have been in force since the publication of the ordinance.

MAPA – MINISTRY OF AGRICULTURE AND LIVESTOCK

MAPA, Anvisa and Ibama publish joint ordinances to optimize pesticide registration procedure

On November 03, 2023, MAPA, Anvisa and Ibama published Joint Ordinances No. 02 and 03/2023, aimed at:

• providing instructions on the procedures for post-registration changes of pesticides, in order to ensure agility and security in such procedures; and
• streamlining administrative and human resources procedures for purposes that require technical analysis.

MAPA estimates that around 1,400 requests filed before October 2021 are still pending analysis. In addition, about 800 of these requests involve products that are identical to others that have already been registered or are under registration. In this regard, the target is to expand the supply of pesticides through a more efficient registration process, thus increasing the competitiveness of the market.

PUBLIC CONSULTATIONS AND HEARINGS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

Public consultation receives contributions on proposed resolution regarding expanded post-study access, compassionate use, and supply of medicines

On November 03, 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 changes concern the risk analysis involved in administrative proceedings, which is not taken into consideration in the current procedure. Among these changes, we highlight:

• Healthcare program for compassionate use and changes in healthcare programs: analyzed according to the risk involved. Implementation will only be subject to Anvisa’s approval in cases that involve higher risk, while other cases will only require notification to Anvisa.
• Post-study supply of medicines: only notification to Anvisa is required.

Contributions may be sent by January 02, 2024, through the online form.

Public consultation analyzes proposed normative instruction on food registration requested through AREE evidentiary documents

On November 27, 2023, Public Consultation No. 1,217/2023 was published to obtain contributions on the proposed normative instruction that establishes conditions regarding an optimized procedure for  analysis of evaluation petitions in the food industry through the admission of evidentiary documents issued by the Equivalent Foreign Regulatory Authority (“AREE”).

In August 2022, Anvisa published Collegiate Board Resolution No. 741/2022, which established the general criteria for the admission of analyses performed by an AREE. However, a specific regulation to provide for the foods sector has yet to be published. As such, the proposed normative instruction establishes general criteria for the admission and analysis of these requests.

Contributions can be sent by March 02, 2024, through the online form.

Proposed revision of Brazilian Common Denomination regulation subject to public consultation

On November 28, 2023, Public Consultation No. 1,219/2023 was published to obtain contributions on the proposed review of the regulations that form the legal framework of Brazilian Common Denominations (“DCB”).

According to Anvisa, the proposed resolution does not aim to change existing DCBs, but rather adjust and consolidate existing regulations to make the process faster and more transparent. 

Contributions can be sent by February 02, 2024, through the online form.

Proposed resolution to amend Cosmetovigilance System subject to public consultation

On November 28, 2023, ANVISA opened Public Consultation No. 1,220/2023 to receive contributions on a proposed resolution that:

• Provides for “Good Practices of Cosmetovigilance” for companies that have registered cosmetics for human use with Anvisa; and
• Repeals Collegiate Board Resolution No 332/2005, which provides for the mandatory nature of the Cosmetovigilance system.

According to Anvisa, the proposal to review the regulations on the current cosmetovigilance system seeks to address the low effectiveness of the current regulation (Collegiate Board Resolution No. 332/2005) to structure effective cosmetovigilance systems in companies in the cosmetics sector. As such, the proposal seeks to establish requirements for the implementation, structuring, operation and continuation of cosmetovigilance systems, as well as the detailing of guidelines to inspection and monitoring actions.

Contributions can be sent by February 02, 2024, through the online form.

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

Open Data Policy subject to public consultation

Throughout November 2023, the Ministry of Health received contributions regarding the use of open data within SUS.

The public consultation aimed to consolidate contributions regarding improvements in the process to share open data, and regarding the development of an Open Data Policy for 2024 and 2025, to ensure governmental transparency, improve government service and expand data connectivity within the current SUS digital health environment.