Life Sciences Newsletter No. 25

Check out our monthly Life Sciences Newsletter, which gathers information on recent legislation, news, public consultations and bills related to the Brazilian health and agriculture sectors.

For more information, please contact our lawyers.

Enjoy reading!

Demarest’s Life Sciences Team

NEWS

ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY

Brazil approves first injectable HIV treatment

On June 05, 2023, Anvisa published authorization for the use of the first injectable medication against HIV in Brazil.

Currently, pre-exposure prophylaxis (PrEP) is already available in the form of oral daily tablets. Similarly, the new injectable treatment also prevents the risk of HIV transmission, but stands out for its long-acting effectiveness, which only requires injections every two months.

A specific date for the sale of cabotegravir (injectable PrEP) in Brazil has yet to be defined.

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

ANS sets price adjustment limit for individual and family healthcare plans

On June 12, 2023, ANS approved a 9.63% price adjustment limit for individual and family healthcare plans.

This limit was also approved by the Ministry of Finance and will be valid force from May 2023 to April 2024.

The final percentage limit was mainly influenced by factors such as inflation, variations in the healthcare plan’s frequency of usage, and the costs of medical services and inputs.

ANS also published data relating to the sector’s expenses.

FEDERAL GOVERNMENT

House of Representatives approves Mais Médicos provisional measure

On June 14, 2023, the Brazilian House of Representatives approved a provisional measure that provides for the Mais Médicos program (“MP 1165/2023”).

The regulation includes amendments rooted in opinions supported by the Brazilian Federal Council of Medicine (“CFM”). The main CFM arguments in this regard, which have been approved are:

• Enforcement of “Revalida”: These assessments are aimed at recertifying physicians enrolled in the program to practice in Brazil and will be held three times a year.
• Waiver from “Revalida”: Foreign physicians can stay enrolled in the program for up to four years.
• 2nd phase of “Revalida”: Candidates approved in recurring evaluations throughout a 48-month period must take the practical exam in the 2nd stage of
• Tutor: Professionals enrolled in Mais Médicos must be supervised by a registered physician.
• Compensation: The Ministry of Health will establish the number of annual slots available for monetary compensation – without the need to apply.

Following this approval, the Federal Senate is expected to evaluate the provisional measure by July 16, 2023.[/vc_column_text][vc_empty_space height=”40px”][vc_separator border_width=”3″][vc_empty_space height=”40px”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]LEGISLATIONS

FEDERAL GOVERNMENT

“Farmácia Popular” program reinstated

On June 07, 2023, Decree No. 11,555/2023 reinstated the “Farmácia Popular do Brasil” program (in English, “People’s Pharmacy of Brazil”).

The program was created in 2004 and involved agreements with the government to provide more accessible medicines through low-cost and private sector drugstores.

Bolsa Família beneficiaries and members of the indigenous community in Brazil will have access to medicines free from charge. In parallel, the government will partially or fully fund medicines sold in drugstores of the private sector.

What is more, the decree prioritizes the accreditation of pharmaceutical establishments located in the most socially vulnerable cities that have also joined the “Mais Médicos” program.

Find out more on our Client Alert published in June 2023.

ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY 

Resolution authorizes sale of vaccines and medicines for emergency use

On June 05, 2023, RDC No. 801/2023 was published and entered into force, authorizing the use, sale and dispensing of vaccines and medicines that have been approved for emergency use under RDC No. 688/2022.

The new regulation authorizes the use, sale and dispensing of all vaccines and medicine batches that were approved for emergency use on May 21, 2023.

These batches must have been produced before May 21, 2023 and still be within their shelf life.

FEDERAL GOVERNMENT

New regulation requires resting spaces for nursing professionals

On June 21, 2023, Law No. 14,602/2023 was published in the Federal Official Gazette of Brazil, establishing requirements in regard to nursing professionals’ resting conditions during working hours.

The new regulation adds Article 15-E to Law No. 7,498/1986, which provides for the duties of public and private health institutions about the provision of resting spaces for nursing professionals.

These spaces must be:

• allocated specifically for nursing professionals resting periods;
• appropriately ventilated;
• equipped with appropriate furniture;
• thermally and acoustically comfortable;
• equipped with sanitary facilities; and
• large enough to accommodate all nursing professionals on a daily basis.

ANS  – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

Legislation changes regarding monitoring activities of the ANS

On June 23, 2023,  Normative Resolution No. 579/2013 was published, which amended procedures carried out by the ANS in order to structure and execute monitoring activities provided for in Normative Resolution No. 483/2022.

Normative Resolution No. 483/2022, which provides for Notice of Preliminary Intermediation (NIP), underwent the following changes:

Also, considering the exclusion of the third notification phase (previously provided for in subsection V of Section I of Chapter III of Normative Resolution No. 483/2022), only demands classified as “pending” will move forward to an administrative sanctioning proceeding, while any other demands will be resolved after the classification phase.

These changes entered into force on July 03, 2023.

]PUBLIC CONSULTATIONS AND PUBLIC HEARINGS

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

New public consultation aims at the regulation of extrajudicial liquidation proceedings adjudicated by the ANS

On June 13, 2023, the ANS published Public Consultation No. 111/2023, in order to obtain contributions regarding a draft normative instruction to provide for the contracting of services and other expenses addressed in Normative Resolution No. 524, Of April 29, 2022, within the scope of extrajudicial liquidations adjudicated by the ANS.

Access here the channel to submit contributions.

MAPA – MINISTRY OF AGRICULTURE, LIVESTOCK AND FOOD SUPPLY

Public consultation: Carbono + Verde program

On June 05, 2023, a public consultation was opened to obtain contributions regarding the development of a National Program for Decarbonized Agriculture Chains, widely known as the “Carbono + Verde” program (in English, Greener Carbon Program).

The goal is to stimulate low-carbon primary agricultural production to encourage sustainable on the fields. The MAPA aims to use the participation and approval from the public as a strategy to build the credibility of low-carbon production.

Contributions can be submitted by August 05, 2023.

Access here the channel to submit contributions.