3/24/2020
The Presidency, together with the Ministry of Health and the National Health Surveillance Agency (Anvisa) have adopted, almost daily, important measures to combat the Coronavirus (Covid-19). This is the case of Law No. 13,979, which provides for measures to deal with the public health emergency of international importance.
In order to protect the community and prevent contamination or the spread of Coronavirus, the standard, which has been widely applied, provides for several actions, ranging from quarantine (restriction of activities or separation of people and / or objects suspected of contamination), or isolation (separation of contaminated people and / or objects), until the temporary closure of ports, highways and airports for entering and leaving the country.
While restricting the free movement of people and the exercise of economic activities, the Law promises to facilitate access to medicines and various health products, dispensing with the bidding process for the acquisition of goods, services and health supplies intended to face the emergency.
It is important to emphasize, however, that the Law will only be effective as long as the national emergency situation lasts, considering the period declared by the World Health Organization, and, therefore, the exemption is temporary.
In view of the severity of the current health crisis and the different levels of the disease stage in the world, the measures already established may remain in force for a longer time, until the resumption of normality.
In order to operationalize and regulate the Law, the Ministry of Health published, on March 11, an Ordinance that establishes that:
- The 14-day period for isolation, provided that determined by medical prescription, and can be extended for another 14 days in case of risk of virus transmission;
- The quarantine should be up to 40 days, and may be extended for as long as necessary to reduce transmission. The measure must be determined in a formal act and duly motivated by the Secretary of Health or higher.
- Failure to comply with the isolation measures will result in accountability, and it is up to the doctors or epidemiological health surveillance agents to inform the police authority and the Public Prosecutor’s Office about the breach. The agents, in turn, have the authority to carry out the legal determinations, which are not guidelines, but coercive measures.
- The conditions for applying public health emergency coping measures are provided for in the Epidemiological Bulletin, which should be updated periodically, and in the National Contingency Plan for Human Coronavirus Infection (COVID-19).
In addition, the National Contingency Plan includes three levels of response and the corresponding command structure for each level of response: Alert, Imminent Danger and Emergency in Public Health. Each level is based on the assessment of risk and its impact on public health.
Regarding sanitary actions, Anvisa published two Resolutions related to extraordinary and temporary procedures due to the Coronavirus.
The first of them is RDC nº 346, dated 12 March, which defines the extraordinary criteria and procedures for certification of Good Manufacturing Practices (GMP) for the purposes of registration and post-registration changes of medicines, supplies and health products. The measure was adopted to minimize the impacts, considering that the scenario makes the sanitary inspection in loco in the manufacturers’ international plants unfeasible.
Alternative and temporary GMP certification mechanisms will only be applied to petitions already filed with the Agency before the DRC came into effect. Exceptionally, however, the same measures may be used for new orders. In this case, the medication or health product should be used to control, diagnose, prevent or treat needs related to Coronavirus.
The temporary GMP certification will be valid for 180 days from March 13, and the standard may have a renewed term. Once validity is over, the sector responsible for health inspection and inspection will adopt, as a priority, the conventional certification mechanisms.
The second standard, RDC nº 348, of 17 March, establishes the extraordinary criteria and procedures for registering medicines and biological products. In this case, the registration will have a validity period of 1 year, with some exceptions.
Both standards emphasize that the priority of the procedures will only apply in the case of a proven threat of shortages in the national market due to the Coronavirus.
Government institutes Crisis Committee for Supervision and Monitoring of Coronavirus Impacts
Faced with the scenario of disease progression in Brazil, the Federal Government recently instituted the Crisis Committee for Supervision and Monitoring of Coronavirus Impacts, with representatives from various Ministries.
In addition, it approved the reduction of the import tax rate for 50 medical and hospital products necessary to combat the pandemic. Among which are gloves, alcohol gel, masks, thermometers, protective clothing for infectious agents, among others.
As part of the actions, daily Anvisa has been publishing new measures aiming at the release for trade of essential products to fight the pandemic, such as the possibility of manufacturing and commercializing antiseptic preparations without prior authorization.
Our Regulatory area team is available to address questions related to this topic and other matters.
