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.
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Demarest’s Life Sciences Team
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
ANVISA clarifies ban on advertising of Cannabis products
In August 2023, Anvisa published a warning against the advertising of Cannabis Products, stressing that the practice is forbidden in cases that involve exceptional authorization for exclusive import by individuals.
Additionally, Anvisa clarified that only drugs regulated through Collegiate Board Resolution – “RDC” No. 96/2008can be advertised, which does not include Cannabis Products, which are regulated by RDC No. 327/2019 and are not classified as medicines.
ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY
ANS evaluates classification of advanced therapies
In August 2023, the ANS evaluated the classification of advanced therapy medicines, which resulted in Technical Note No. 3/2023/GCITS/GGRAS/DIRAD-DIPRO/DIPRO , in alignment with the 594th meeting of the collegiate board of the ANS.
According to the ANS, “Advanced Therapy Medicinal Products” are special medicines and thus are not included in the outpatient care provided through procedures that are already included in the list of mandatory procedures. As such, such products will only be covered by healthcare plans if they have been included previously in the list of mandatory procedures that applies to the treatment or therapy provided through each of these medicines.
The significance of this matter lies in the fact that healthcare plans would be obliged to include such products in the coverage if classified as simple medicines, regardless of whether the products are part of the ANS’ list of mandatory procedures, as provided for in the the Healthcare Plans Law (Article 12, item II, subitem d).
FEDERAL GOVERNMENT
New PAC of the Federal Government will include investments in the health sector
On August 11, 2023, the Brazilian Federal Government announced the New Growth Acceleration Program (“New PAC”) aimed at the fostering of investments in public policies, particularly within the context of economic, social and urban infrastructure.
The investment forecast in the health sector amounts to BRL 31 billion, which will be allocated for:
- building new basic health units, polyclinics, maternity hospitals, as well as purchasing more ambulances to expand access to specialized treatment;
- investing in the medical-industrial complex, bolstering the supply of vaccines and blood products;
- investing in telehealth to increase the efficiency of care to the population.
MS – BRAZILIAN MINISTRY OF HEALTH
Bill regarding mandatory infrastructure for people with disabilities moves forward to the House of Representatives
On August 02, 2023, the Brazilian Committee on Social Affairs (“CAS”) approved Bill No. 3692/2019, which obliges medium and large-sized hospitals and health facilities to have proper equipment for people with disabilities.
The bill is aimed at improving accessibility in healthcare spaces, to ensure that patients with disabilities receive efficient treatment. Accordingly, the provision of such infrastructure is in line with the principles of universality and integrality of healthcare provided for in the Brazilian Constitution.
If the House of Representatives passes the bill, the new law will enter into force one year after its publication.
ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY
ANVISA approves home delivery of controlled medicines
In August 2023, Anvisa approved the home delivery of medicines through RDC No. 812/2023.
The resolution permanently authorizes the home delivery of medicines that are subject to special control (controlled medicines), which had been previously allowed on a temporary basis due to the COVID-19 pandemic and the consequent Public Health Emergency of International Concern (PHEIC).
The delivery of these products is subject to the same rules as in-person sales, that is, the dispensing establishment must retain the original controlled substance prescriptions, as well as comply with the requirements and procedures provided for in the resolution. Regardless of these changes, the online purchase and sale of controlled medicines remains prohibited.
Find out more in our client alert – “Anvisa definitely authorizes remote delivery of controlled medicines” .
Anvisa establishes rules regarding Single Import Declaration
On August 08, 2023, Anvisa published RDC No. 807/2023 , which regulates the import, through a Single Import Declaration (“Duimp”), of goods and products that are subject to health oversight.
Duimp is an alternative import method for products that are subject to Anvisa’s approval, which is now expected to occur more simply and efficiently. Anvisa expects the standardization and centralization of the procedure will significantly reduce costs in the sector.
While the transition to Duimp will occur gradually, Anvisa has yet to announce the list of products encompassed in the new regulation.
Find out more in our client alert – “ANVISA approves import of products through a Single Declaration” .
Changes in clinical research and trial procedures aim to speed up the approval process
On August 21, 2023, Anvisa published RDC No. 811/2023, amending Resolutions No. 204/2017 and No. 205/2017 which provide for the procedures to request approval for priority clinical research and trials, as well as for the registering application of new medicines that treat rare diseases.
The new regulation establishes that requests for approval that fall under either of these circumstances will be assessed within 45 days by Anvisa, which will be in charge of verifying the classification of the request.
Prior to this change, requests submitted within the wrong category were automatically denied without an in-depth assessment of topic or option to resubmit the request, which, according to Anvisa’s Collegiate Board, was a potentially unreasonable practice.
Anvisa changes labeling rules for personal hygiene and sanitizing products
In August, 2023, Anvisa published Normative Instructions No. 242/2023 and No. 243/2023, which establish labeling criteria regarding formula modifications in personal hygiene products, such as disposable products, cosmetics and perfumes; as well as sanitizers.
The new regulation repeals Normative Instructions No. 69/2020 and No. 157/2022, which did not establish such criteria to inform customers of new formulas. As a result, the new regulation specifies which information fall under such criteria of qualitative or quantitative changes in the formula:
- concentration of component(s), resulting in changes, exclusion or insertion of mandatory wording;
- instructions for use;
- warnings, first aid and restrictions of use; and
- new effects or benefits of the product.
In these cases, the label must inform customers of a “NEW FORMULA” – or “NEW COMPOSITION” for hygiene products.
Anvisa simplifies medical device import regulation
On August 18, 2023, Anvisa published RDC No. 810/2023, which updates the regulation on the import of medical devices listed in RDC No. 751/2022, providing for risk classification, notification and registration systems, labeling requirements and instructions for use of such devices.
As such, import processes registered as of June 18, 2023, will be authorized to include medical devices and accessories that were industrialized prior to the publication of notice or registration, as long as such time lapse does not exceed five years, and in accordance with the due health regulation.
Before the resolution, the regulation only authorized the import of medical devices industrialized after the publication of notice or registration. This measure is aimed at expanding access to medical devices, given that such products are not produced exclusively within the Brazilian market.
ANVISA changes medicine labeling regulation
On August 08, 2023, Anvisa published RDC No. 808/2023, which provides for changes in RDC No. 768/2022, regarding the labeling of medicines.
Anvisa stated that the changes are aligned with current market practices, in addition to reinforcing the restrictions established in the previous resolution. Among these changes, we highlight that:
- Packages must inform the total amount of the medicine on the front label.
- Tall man lettering use is only mandatory for medicines that can only be provided by health facilities and for presentations relating to such facilities.
- Secondary packaging of medicines sold to the Federal Government must include the terms “USE WITH PRESCRIPTION ONLY” and “USE WITH PRESCRIPTION RETENTION” – the previous terms were “SOLD BY PRESCRIPTION ONLY” and “SOLD BY PRESCRIPTION RETENTION”, respectively.
These changes are already in force and companies in the sector must comply with the new regulation.
Technical chamber created to provide recommendations on the registration of medicines and biological products
On August 14, 2023, Anvisa published Ordinance No. 875/2023, which created the Technical Chamber of Medicine Registration (“Cateme”), whose members will conduct technical studies in order to provide scientific evidence and recommendations regarding the registration of medicines and biological products.
Through Cateme, Anvisa aims to deepen discussions concerning the registration of such medicines, given the narrow variety of the sector regarding offers to consumers and hospitals. The chamber will be formed by ten members, who will attend quarterly ordinary meetings and extraordinary meetings throughout a three-year term.
ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY
New regulation on replacements and reduction within the hospital network of healthcare plans
On August 24, 2023, the ANS published Law No. 585/2023, which provides for:
- criteria associated with changes within the hospital network in regard to the replacement of hospitals and reduction of the network; and
- the amendment of Normative Resolution No. 489, of March 29, 2022, which provides for the enforcement of penalties relating to violations against the regulation of private healthcare plans.
Among the main changes is the replacement of hospitals by equivalent facilities located in the same city. Additionally, the reduction of the network is authorized if the hospital to be excluded has not been responsible for up to 80% of hospitalizations in its service area in the last 12 months.
Find out more in our client alert – “New regulation regarding hospital replacement and reduction by healthcare plans” .
FEDERAL GOVERNMENT
New law requires online information regarding availability of medicines in SUS pharmacies
On August 24, 2023, the Ministry of Health approved Law No. 14,654/23, which establishes the mandatory update, every two weeks, of an online medicine availability database in pharmacies within the Brazilian Unified Health System (“SUS”).
The new regulation is aimed at improving the population’s access to information about the medicine stock in the public health system. Additionally, the system’s transparency will enable competent authorities to prevent the shortage of medicines through continuous monitoring of the database.
Law No. 14,651/23 will enter into force 180 days after its official publication.
MAPA – MINISTRY OF AGRICULTURE, LIVESTOCK AND FOOD SUPPLY
MAPA approves transport and certification procedures of animal by-products
On August 15, 2023, MAPA published Ordinance No. 871/2023, which approved procedures for the transport and health certification of specific non-edible animal by-products for industrial or technical use; livestock waste transport; and health certification of products obtained from animal sources for a specific purpose.
MAPA aims to ensure that such by-products are in compliance with the health certification requirements of importing countries. Among the requirements established by the ordinance are:
- registration of facilities;
- issuance of By-products Transport Form; and
- an international health certification.
Ordinance amends technical regulation regarding pre-slaughter handling
On July 31, 2023, MAPA published Ordinance No. 864/2023 , to amend Ordinance No. 365/2021, which approved the Pre-slaughter and Humane Slaughter Technical Regulation, as well as any associated stunning methods.
Among the changes are:
- procedures for the handling of fetuses in the slaughter of gestating animals;
- prohibition against the transport of female bovines and bubalines that show signs of giving birth;
- new requirements for mechanical stunning equipment.
PUBLIC HEARINGS AND CONSULTATIONS
MAPA – MINISTRY OF AGRICULTURE, LIVESTOCK AND FOOD SUPPLY
Public consultation seeks to establish technical regulation regarding dairy beverages
On August 01, 2023, MAPA opened a public consultation to obtain contributions regarding a draft technical regulation aimed at establishing identification and quality standards for dairy beverages.
MAPA received contributions until September 15, 2023 through its online page to ensure that the classification of products as dairy beverages matches its ingredients composition, which must be, at least, 51% dairy-based.
In addition, MAPA established specific criteria regarding:
- pasteurized dairy beverage;
- sterilized dairy beverage;
- ultra-high temperature dairy beverages; and
- dairy beverage treated with heat, after fermentation.
The proposal suggests a one-year adjustment deadline for companies affected by the new regulation.
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